FDA Product Code
FDA Product Code NBW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1345
510(k) Clearances — 511 records · page 1 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260689 | CVS Advanced PLUS Blood Glucose Monitoring System | I-Sens, Inc. | 2026-10-02 | Special | PDF ↗ |
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2026-08-27 | Traditional | PDF ↗ |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose System | Trividia Health, Inc. | 2026-07-23 | Special | PDF ↗ |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | ACON Laboratories, Inc. | 2025-10-10 | Traditional | PDF ↗ |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical Electronics Co., Ltd. | 2025-01-30 | Traditional | PDF ↗ |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | 2024-11-04 | Traditional | PDF ↗ |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System | Sejoy Biomedical Co., Ltd. | 2024-10-08 | Traditional | PDF ↗ |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2024-08-27 | Traditional | PDF ↗ |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-08-16 | Traditional | PDF ↗ |
| K241304 | WaveSense Jazz Blood Glucose Monitoring System | Agamatrix | 2024-06-06 | Special | PDF ↗ |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2024-02-23 | Traditional | PDF ↗ |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | 2024-01-19 | Traditional | PDF ↗ |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-12-22 | Traditional | PDF ↗ |
| K231476 | TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System | Sinocare, Inc. | 2023-12-01 | Traditional | PDF ↗ |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH | 2023-08-10 | Traditional | PDF ↗ |
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | I-Sens, Inc. | 2023-08-10 | Special | PDF ↗ |
| K223722 | MIO Blood Glucose Monitoring System | Mio Labs, Inc. | 2023-06-28 | Traditional | PDF ↗ |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2022-12-21 | Special | PDF ↗ |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2022-11-18 | Special | PDF ↗ |
| K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2022-11-04 | Special | PDF ↗ |
| K213061 | SuperCheck Pro Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | 2022-10-07 | Traditional | PDF ↗ |
| K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring System | Hmd Biomedical, Inc. | 2022-08-29 | Special | PDF ↗ |
| K212140 | GlucoSure Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2022-08-25 | Traditional | PDF ↗ |
| K202739 | Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System | Bioland Technology, Ltd. | 2022-08-12 | Special | PDF ↗ |
| K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System | Taidoc Technology Corporation | 2022-06-16 | Traditional | PDF ↗ |
| K203711 | IWL2020 Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | 2022-05-06 | Traditional | PDF ↗ |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring System | Apex BioTechnology Corp. | 2022-04-06 | Traditional | PDF ↗ |
| K213887 | GAL-1A Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2022-03-29 | Special | PDF ↗ |
| K193406 | CardioChek Plus Test System; CardioChek Plus Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2022-02-26 | Traditional | PDF ↗ |
| K193407 | Contour® next GEN Blood Glucose Monitoring System | Ascensia Diabetes Care | 2021-12-23 | Traditional | PDF ↗ |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring System | Apex BioTechnology Corp. | 2021-10-15 | Traditional | PDF ↗ |
| K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System | I-Sens, Inc. | 2021-10-05 | Special | PDF ↗ |
| K202885 | GlucoSure HT Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2021-09-15 | Special | PDF ↗ |
| K201258 | EASYMAX Tag Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. | 2021-09-01 | Special | PDF ↗ |
| K210687 | CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2021-08-11 | Special | PDF ↗ |
| K203562 | Finetest Lite Blood Glucose Monitoring System | Osang Healthcare Co. , Ltd. | 2021-07-13 | Special | PDF ↗ |
| K201396 | Finetest Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co. , Ltd. | 2020-10-16 | Special | PDF ↗ |
| K193340 | GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System | Microtech Medical, Inc. | 2020-09-11 | Traditional | PDF ↗ |
| K200277 | Livongo Blood Glucose Monitoring System (BG1000) | Livongo Health, Inc. | 2020-06-04 | Traditional | PDF ↗ |
| K191657 | Bioland Blood Glucose Monitoring System | Bioland Technology, Ltd. | 2020-03-20 | Traditional | PDF ↗ |
| K193475 | OneTouch Verio Reflect Blood Glucose Monitoring System | Lifescan Europe GmbH | 2020-02-14 | Traditional | PDF ↗ |
| K192859 | CareSens S Clear BT Blood Glucose Monitoring System | I-Sens, Inc. | 2020-01-24 | Special | PDF ↗ |
| K193590 | CareSens S Fit BT Blood Glucose Monitoring System | I-Sens, Inc. | 2020-01-17 | Special | PDF ↗ |
| K192220 | ReliOn Premier Classic Blood Glucose Monitoring System | I-Sens, Inc. | 2019-12-13 | Special | PDF ↗ |
| K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System | Ascensia Diabetes Care | 2019-11-08 | Special | PDF ↗ |
| K190189 | MDT2 BLE Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. | 2019-11-01 | Special | PDF ↗ |
| K192175 | On Call Express II Blood Glucose Monitoring System | ACON Laboratories, Inc. | 2019-10-17 | Special | PDF ↗ |
| K191038 | On Call Express Voice Blood Glucose Monitoring System | ACON Laboratories, Inc. | 2019-06-12 | Special | PDF ↗ |
| K190579 | TD-4183 Blood Glucose Monitoring System | Taidoc Technology Corporation | 2019-06-04 | Traditional | PDF ↗ |
| K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB | Bionime Corporation | 2019-06-02 | Traditional | PDF ↗ |
| K182428 | GlucoLeader Enhance Blood Glucose Monitoring System | Hmd Biomedical, Inc. | 2019-05-08 | Traditional | PDF ↗ |
| K183306 | GLUCOCARD® W onyx Blood Glucose Monitoring System | Arkray Factory, Inc. | 2019-04-10 | Special | PDF ↗ |
| K181070 | iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) | Andon Health Co, Ltd. | 2019-02-01 | Traditional | PDF ↗ |
| K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System | Vivachek Laboratories, Inc. | 2018-12-19 | Traditional | PDF ↗ |
| K181131 | Accu-Chek Guide Me Blood Glucose Monitoring System | Roche Diabetes Care | 2018-12-13 | Special | PDF ↗ |
| K182046 | Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | 2018-11-30 | Special | PDF ↗ |
| K181588 | POPS! one Blood Glucose Monitoring System | Taidoc Technology Corporation | 2018-11-30 | Traditional | PDF ↗ |
| K182047 | Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | 2018-11-29 | Special | PDF ↗ |
| K182992 | BGM014 Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2018-11-28 | Special | PDF ↗ |
| K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System | I-Sens, Inc. | 2018-11-01 | Special | PDF ↗ |
| K181527 | On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System | ACON Laboratories, Inc. | 2018-10-03 | Traditional | PDF ↗ |
| K182286 | Oh'Care Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co. , Ltd. | 2018-09-19 | Special | PDF ↗ |
| K180866 | CareSens S Fit Blood Glucose Monitoring System | I-Sens, Inc. | 2018-08-31 | Traditional | PDF ↗ |
| K182057 | EasyMax BT Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. | 2018-08-24 | Special | PDF ↗ |
| K173658 | Confidence Blood Glucose Monitoring System | Applied Biomedical, LLC | 2018-08-21 | Traditional | PDF ↗ |
| K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus | Bionime Corporation | 2018-08-17 | Traditional | PDF ↗ |
| K173505 | FORA GTel Blood Glucose Monitoring System | Foracare, Inc. | 2018-08-09 | Traditional | PDF ↗ |
| K173511 | ActiveCare TD-4121 Blood Glucose Monitoring System | Taidoc Technology Corporation | 2018-07-12 | Special | PDF ↗ |
| K173139 | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus | Bionime Corporation | 2018-06-19 | Traditional | PDF ↗ |
| K181316 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | 2018-06-14 | Special | PDF ↗ |
| K172723 | Dario LC Blood Glucose Monitoring System | Labstyle Innovation, Ltd. | 2018-03-23 | Traditional | PDF ↗ |
| K180196 | On Call Express Mobile Blood Glucose Monitoring System | ACON Laboratories, Inc. | 2018-03-07 | Special | PDF ↗ |
| K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System | I-Sens, Inc. | 2017-12-13 | Special | PDF ↗ |
| K170464 | StatStrip Xpress Blood Glucose Monitoring System | Nova Biomedical Corporation | 2017-11-07 | Traditional | PDF ↗ |
| K163087 | PixoTest Blood Glucose Monitoring System | Ixensor Company , Ltd. | 2017-11-02 | Traditional | PDF ↗ |
| K170614 | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System | I-Sens, Inc. | 2017-10-19 | Special | PDF ↗ |
| K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System | Sd Biosensor | 2017-10-17 | Traditional | PDF ↗ |
| K170241 | GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System | All Medicus Co., Ltd. | 2017-10-13 | Traditional | PDF ↗ |
| K170079 | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | 2017-10-06 | Traditional | PDF ↗ |
| K170264 | Gold AQ Blood Glucose Monitoring System | Changsha Sinocare, Inc. | 2017-10-05 | Traditional | PDF ↗ |
| K171941 | FreeStyle Precision Neo Blood Glucose Test Strips | Abbott Diabetes Care, Inc. | 2017-09-27 | Traditional | PDF ↗ |
| K171822 | NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) | Biotest Medical Corporation | 2017-09-20 | Special | PDF ↗ |
| K171785 | WowGoHealth Blood Glucose Monitoring System | Biotest Medical Corporation | 2017-09-15 | Special | PDF ↗ |
| K170231 | iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) | Andon Health Co, Ltd. | 2017-09-15 | Traditional | PDF ↗ |
| K170064 | GLUCOCARD W Blood Glucose Monitoring System | Arkray Factory, Inc. | 2017-08-16 | Traditional | PDF ↗ |
| K163159 | Dario Blood Glucose Monitoring System | Labstyle Innovations, Ltd. | 2017-07-19 | Traditional | PDF ↗ |
| K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, | Bionime Corporation | 2017-07-06 | Traditional | PDF ↗ |
| K162564 | Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System | Tianjin Empecs Medical Device Co., Ltd. | 2017-06-07 | Traditional | PDF ↗ |
| K161790 | iGlucose Blood Glucose Monitoring System | Bionime Corporation | 2017-05-02 | Traditional | PDF ↗ |
| K160179 | VivaChek Ino Blood Glucose Monitoring System | Vivachek Laboratories, Inc. | 2017-04-21 | Traditional | PDF ↗ |
| K162382 | Smart Dongle Blood Glucose Monitoring System | Taidoc Technology Corporation | 2017-04-14 | Traditional | PDF ↗ |
| K162203 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | 2017-04-06 | Traditional | PDF ↗ |
| K152534 | Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System | Tianjin Empecs Medical Device Co., Ltd. | 2017-03-21 | Special | PDF ↗ |
| K170267 | BGM009 Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2017-03-09 | Special | PDF ↗ |
| K153561 | AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System | Andon Health Co, Ltd. | 2017-02-16 | Traditional | PDF ↗ |
| K162430 | UniStrip1 Generic Blood Glucose Test Strips | Ok Biotech Co., Ltd. | 2017-01-19 | Traditional | PDF ↗ |
| K162336 | Contour Next EZ Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2017-01-12 | Special | PDF ↗ |
| K161299 | BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2016-12-23 | Traditional | PDF ↗ |
| K160742 | NoCoding1 Plus Blood Glucose Monitoring System | I-Sens, Inc. | 2016-12-16 | Traditional | PDF ↗ |
| K161834 | One Drop Blood Glucose Monitoring System | Agamatrix, Inc. | 2016-11-30 | Special | PDF ↗ |
Product code NBW · Class II · Clinical Chemistry. Data: openFDA.