FDA Product Code
FDA Product Code CFR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1345
510(k) Clearances — 145 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics | 2026-02-12 | Traditional | PDF ↗ |
| K252357 | Glucose2 | Abbott Ireland | 2025-10-24 | Traditional | PDF ↗ |
| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH | Roche Diagnostics | 2022-09-16 | Traditional | PDF ↗ |
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions | Roche Diagnostics | 2019-08-16 | Traditional | PDF ↗ |
| K170316 | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | Abbott Laboratories | 2017-10-19 | Traditional | PDF ↗ |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II | Elitechgroup | 2016-09-07 | Traditional | PDF ↗ |
| K151487 | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method | Diatron U.S., Inc. | 2016-01-14 | Traditional | PDF ↗ |
| K131189 | UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) | Beckman Coulter, Inc. | 2014-04-17 | Traditional | PDF ↗ |
| K123018 | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-04-23 | Traditional | PDF ↗ |
| K120681 | ADVIA CHEMISTRY GLUH_3 REAGENTS | Siemens Healthcare Diagnostics, Inc. | 2012-05-15 | Traditional | PDF ↗ |
| K120369 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) | Hitachi Chemical Diagnostics, Inc. | 2012-05-10 | Traditional | PDF ↗ |
| K112377 | BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-03-23 | Traditional | PDF ↗ |
| K113131 | LIASYS 450 | Ams | 2012-03-08 | Traditional | PDF ↗ |
| K103531 | PRESTIGE 24I; BIOLIS 24I; MGC 240 | Tokyo Boeki Medisys, Inc. | 2011-12-01 | Traditional | PDF ↗ |
| K103788 | PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT | HORIBA ABX SAS | 2011-11-08 | Traditional | PDF ↗ |
| K101854 | ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 | Siemens Healthcare Diagnostics | 2011-03-07 | Traditional | PDF ↗ |
| K092603 | COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY | Roche Diagnostics | 2009-12-04 | Special | PDF ↗ |
| K090703 | POLY-CHEM 90 GLUCOSE | Polymedco, Inc. | 2009-10-20 | Traditional | PDF ↗ |
| K092506 | EASYRA GLU-H REAGENT, MODEL 10200 | Medica Corp. | 2009-09-16 | Special | PDF ↗ |
| K081276 | ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H | Horiba Abx | 2008-09-12 | Traditional | PDF ↗ |
| K080468 | LIASYS WITH MODELS LIASYS | Ams S.R.L. Analyzer Medical System | 2008-07-25 | Traditional | PDF ↗ |
| K080123 | APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 | Wako Chemicals USA, Inc. | 2008-07-17 | Traditional | PDF ↗ |
| K072140 | S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 | Traditional | PDF ↗ |
| K072018 | BS-200 CHEMISTRY ANALYZER, MODE BS-200 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-02-01 | Traditional | PDF ↗ |
| K062118 | POINTE 360 | Pointe Scientific, Inc., | 2007-07-13 | Traditional | PDF ↗ |
| K061879 | SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM | Hemodiagnostica, LLC | 2006-12-15 | Traditional | PDF ↗ |
| K062239 | GLUCOSE HK NEW FORMULATION TEST SYSTEM | Roche Diagnostics Corp. | 2006-09-11 | Special | PDF ↗ |
| K061048 | COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM | Roche Diagnostics Corp. | 2006-05-17 | Special | PDF ↗ |
| K060383 | GLUCOSE | Abbott Laboratories | 2006-05-05 | Traditional | PDF ↗ |
| K060256 | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM | Beckman Coulter, Inc. | 2006-02-27 | Special | PDF ↗ |
| K052007 | ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) | Horiba Abx | 2005-12-16 | Traditional | PDF ↗ |
| K052163 | ADVIA IMS GLUCOSE ASSAY | Bayer Healthcare, LLC | 2005-10-11 | Traditional | PDF ↗ |
| K042767 | DATAPRO CLINICAL CHELISTRY ANALYZER | Thermo Electron Corporation | 2005-04-27 | Traditional | PDF ↗ |
| K041052 | RAICHEM GLUCOSE UV (LIQUID) | Hemagen Diagnostics, Inc. | 2004-06-30 | Traditional | PDF ↗ |
| K031135 | GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) | Dade Behring, Inc. | 2003-06-02 | Traditional | PDF ↗ |
| K024281 | WAKO L-TYPE GLUCOSE 2 | Wako Chemicals USA, Inc. | 2003-02-24 | Traditional | PDF ↗ |
| K023739 | GLUCOSE-SL-C ASSAY, MODEL 257-30 | Diagnostic Chemicals , Ltd. | 2003-01-17 | Traditional | PDF ↗ |
| K020852 | POLY-CHEM GLUCOSE | Polymedco, Inc. | 2002-07-03 | Traditional | PDF ↗ |
| K011963 | ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY | Bayer Corp. | 2001-11-20 | Traditional | PDF ↗ |
| K012668 | RAICHEM GLUCOSE UV REAGENT | Hemagen Diagnostics, Inc. | 2001-10-15 | Traditional | PDF ↗ |
| K011900 | GLUCOSE (HEXOKINASE) | Jas Diagnostics, Inc. | 2001-07-31 | Traditional | PDF ↗ |
| K002199 | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | Pointe Scientific, Inc., | 2000-11-20 | Traditional | PDF ↗ |
| K001403 | SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P | Sigma Diagnostics, Inc. | 2000-08-10 | Traditional | PDF ↗ |
| K000556 | ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS | Elan Diagnostics | 2000-05-17 | Traditional | PDF ↗ |
| K000102 | GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 | Teco Diagnostics | 2000-02-08 | Special | PDF ↗ |
| K990981 | GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02 | A.P. Total Care, Inc. | 1999-05-25 | Traditional | PDF ↗ |
| K984574 | INFINITY GLUCOSE REAGENT | Sigma Diagnostics, Inc. | 1999-02-11 | Traditional | PDF ↗ |
| K980883 | N-ASSAY GLU-UL | Crestat Diagnostics, Inc. | 1998-09-03 | Traditional | PDF ↗ |
| K981185 | GLU | Abbott Laboratories | 1998-05-07 | Traditional | PDF ↗ |
| K980026 | GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Trace America, Inc. | 1998-03-10 | Traditional | PDF ↗ |
| K970664 | GLUCOSE REAGENT | Derma Media Lab., Inc. | 1997-08-01 | Traditional | PDF ↗ |
| K971754 | LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | Pointe Scientific, Inc., | 1997-07-22 | Traditional | PDF ↗ |
| K971467 | SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) | Carolina Liquid Chemistries Corp. | 1997-06-16 | Traditional | PDF ↗ |
| K971276 | GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER | Bayer Corp. | 1997-06-16 | Traditional | PDF ↗ |
| K964004 | GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS | Bayer Corp. | 1997-02-10 | Traditional | PDF ↗ |
| K962435 | STC AUTO-LYTE URINARY GLUCOSE ASSAY | OraSure Technologies, Inc. | 1996-12-26 | Traditional | PDF ↗ |
| K953210 | GLUCOSE (HEXOKINASE) KIT | Randox Laboratories, Ltd. | 1996-10-25 | Traditional | PDF ↗ |
| K961282 | GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 | Diagnostic Chemicals , Ltd. | 1996-06-21 | Traditional | PDF ↗ |
| K960084 | HICHEM GLUCOSE/HK REAGENT KIT | Hi Chem, Inc. | 1996-04-04 | Traditional | PDF ↗ |
| K953847 | ROCHE REAGENT FOR GLUCOSE | Roche Diagnostic Systems, Inc. | 1996-02-13 | Traditional | PDF ↗ |
| K952437 | DMA GLUCOSE HEXOKINASE U.V. PROCEDURE | Data Medical Associates, Inc. | 1995-10-03 | Traditional | PDF ↗ |
| K951058 | GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION | Heraeus Kulzer, Inc. | 1995-06-01 | Traditional | PDF ↗ |
| K945908 | GLUCOSE (HK) REAGENT (PROCEDURE NO.16) | Sigma Diagnostics, Inc. | 1995-05-08 | Traditional | PDF ↗ |
| K944406 | OLYMPUS GLUCOSE REAGENT | Olympus America, Inc. | 1995-03-15 | Traditional | PDF ↗ |
| K942963 | GLUCOSE QVET | Prisma Systems | 1994-12-29 | Traditional | PDF ↗ |
| K934900 | GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION | Heraeus Kulzer, Inc. | 1993-12-07 | Traditional | PDF ↗ |
| K931402 | IL TEST GLUCOSE | Instrumentation Laboratory CO | 1993-10-12 | Traditional | PDF ↗ |
| K931890 | GLUCOSE-HK TEST | Em Diagnostic Systems, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K926361 | GLUCOMETER ENCORE QA BLOOD GLUCOSE METER | Heraeus Kulzer, Inc. | 1993-06-24 | Traditional | PDF ↗ |
| K922811 | ROCHE COBAS FUTURA GLUCOSE | Roche Diagnostic Systems, Inc. | 1993-01-27 | Traditional | PDF ↗ |
| K924601 | OLYMPUS GLUCOSE REAGENT | Olympus Corp. | 1992-12-03 | Traditional | PDF ↗ |
| K924572 | EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 | Em Diagnostic Systems, Inc. | 1992-11-25 | Traditional | PDF ↗ |
| K923129 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT | King Diagnostics, Inc. | 1992-11-02 | Traditional | PDF ↗ |
| K923018 | ENCORE TEST STRIPS | Heraeus Kulzer, Inc. | 1992-09-23 | Traditional | PDF ↗ |
| K923040 | MILES URINE GLUCOSE METHOD | Heraeus Kulzer, Inc. | 1992-09-15 | Traditional | PDF ↗ |
| K922232 | OLYMPUS GLUCOSE REAGENT | Olympus Corp. | 1992-07-16 | Traditional | PDF ↗ |
| K914794 | TECHNICON CHEM 1 PLASMA GLUCOSE | Heraeus Kulzer, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K912808 | ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15 | Em Diagnostic Systems, Inc. | 1991-07-30 | Traditional | PDF ↗ |
| K912251 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST | King Diagnostics, Inc. | 1991-07-18 | Traditional | PDF ↗ |
| K905227 | GLUCOSE (HK) REAGENT, UNIVERSAL | Enzyme Technology, Inc. | 1991-03-11 | Traditional | PDF ↗ |
| K905144 | ECLIPSE ICA GLUCOSE | Biotope, Inc. | 1991-01-04 | Traditional | PDF ↗ |
| K901122 | TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE | Technicon Instruments Corp. | 1990-03-29 | Traditional | PDF ↗ |
| K897160 | COULTER GLUCOSE REAGENT | Coulter Electronics, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K896028 | GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600 | American Research Products Co. | 1989-11-14 | Traditional | PDF ↗ |
| K894394 | ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT | Abbott Laboratories | 1989-10-03 | Traditional | PDF ↗ |
| K894483 | GLUCOSE-HK TEST (GLU-HK) ITEM #65415 | Em Diagnostic Systems, Inc. | 1989-09-07 | Traditional | PDF ↗ |
| K891923 | AMRESCO PRODUCT NUMBER 7426 | American Research Products Co. | 1989-06-20 | Traditional | PDF ↗ |
| K884736 | GLUCOSE-HK TEST (GLUC-HK) ITEM #65665 | Em Diagnostic Systems, Inc. | 1989-01-03 | Traditional | PDF ↗ |
| K884021 | EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95 | Em Diagnostic Systems, Inc. | 1988-11-10 | Traditional | PDF ↗ |
| K882334 | ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT | Abbott Laboratories | 1988-08-09 | Traditional | PDF ↗ |
| K880236 | GLUCOSE HEXOKINASE | Tech-Neal Scientific, Inc. | 1988-03-15 | Traditional | PDF ↗ |
| K874846 | GLUCOSE (HEXOKINASE) | Tech-Co, Inc. | 1988-03-03 | Traditional | PDF ↗ |
| K873835 | GLUCOSE-HK REAGENT | Intersect Systems, Inc. | 1987-11-24 | Traditional | PDF ↗ |
| K873936 | MODIFIED PARAMAX GLUCOSE REAGENT | Baxter Healthcare Corp | 1987-11-23 | Traditional | PDF ↗ |
| K871976 | MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919 | Simmler, Inc. | 1987-06-05 | Traditional | PDF ↗ |
| K871456 | ULTRA-VIOLET GLUCOSE REAGENT KIT | Biochemical Trade, Inc. | 1987-04-29 | Traditional | PDF ↗ |
| K863259 | GLUCOSE HK PROCEDURE | Data Medical Associates, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K861311 | GLUCOSE (HEXOKINASE) REAGENT SET | Sterling Diagnostics, Inc. | 1986-04-24 | Traditional | PDF ↗ |
| K860724 | ENZYMATIC GLUCOSE REAGENT (HEXOKINASE) | Trace Scientific , Ltd. | 1986-04-07 | Traditional | PDF ↗ |
| K860625 | GLUCOSE HK-60 ASSAY KIT CAT. #201-39 | Diagnostic Chemicals, Ltd. (Usa) | 1986-03-17 | Traditional | PDF ↗ |
Product code CFR · Class II · Clinical Chemistry. Data: openFDA.