Review Panel
Clinical Toxicology FDA 510(k) Clearances & Devices
- Cleared Devices
- 3,041
- Product Codes (page)
- 24
- Latest Decision
- 2026-09-10
Clearances · page 1 of 31
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K261409 | BioTeke® Multi-Drug Urine Test Cup | Bioteke Corporation (Wuxi) Co., Ltd. | NFT | Class II | 2026-09-10 |
| K261364 | Atellica CH Acetaminophen 2 (ACTM) | Siemens Healthcare Diagnostics, Inc. | LDP | Class II | 2026-07-24 |
| K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | NFT | Class II | 2026-07-17 |
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | Vivachek Biotech (Hangzhou) Co., Ltd. | NFT | Class II | 2026-05-22 |
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx | Guangzhou Wondfo Biotech Co., Ltd. | NFT | Class II | 2026-04-28 |
| K253705 | Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC | DJC | Class II | 2026-03-16 |
| K260355 | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup | WEBEST Biotech,, LLC | NFT | Class II | 2026-03-09 |
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC | NFW | Class II | 2026-02-12 |
| K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | DJG | Class II | 2026-01-29 |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | DJG | Class II | 2026-01-23 |
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. | DJG | Class II | 2026-01-16 |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific,, LLC | NGL | Class II | 2025-12-23 |
| K251674 | Fenom Flo FeNO Monitoring System | Mgc Diagnostics Corporation | MXA | Class II | 2025-11-26 |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx | Guangzhou Wondfo Biotech Co., Ltd. | NFT | Class II | 2025-11-18 |
| K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup | Advin Biotech, Inc. | NFT | Class II | 2025-10-09 |
| K250609 | Sober Self-Test | Sober Ip, LLC | DIC | Class II | 2025-09-15 |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | Vivachek Biotech (Hangzhou) Co., Ltd. | NFT | Class II | 2025-09-12 |
| K252520 | SEFRIA Hydrocodone Oral Fluid | Immunalysis Corporation | DJG | Class II | 2025-09-11 |
| K243926 | Vivatmo pro-S | Bosch Healthcare Solutions GmbH | MXA | Class II | 2025-09-11 |
| K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. | NFT | Class II | 2025-08-27 |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | NFT | Class II | 2025-08-15 |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | Healgen Scientific,, LLC | DJG | Class II | 2025-08-15 |
| K243462 | Diazyme Colorimetric Lithium Assay | Diazyme Laboratories, Inc. | NDW | Class II | 2025-08-01 |
| K243500 | ARCHITECT iGentamicin | Abbott Laboratories | LCD | Class II | 2025-07-09 |
| K251634 | LZI Fentanyl III Enzyme Immunoassay | Lin-Zhi International, Inc. | DJG | Class II | 2025-06-18 |
| K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | Anhui Deepblue Medical Technological Co., Ltd. | NGL | Class II | 2025-04-15 |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | NFT | Class II | 2025-04-04 |
| K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | Hangzhou Laihe Biotech Co., Ltd. | DJC | Class II | 2025-03-18 |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. | NFT | Class II | 2025-02-27 |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | Guangzhou Decheng Biotechnology Co., Ltd. | NGL | Class II | 2025-02-20 |
| K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | NFT | Class II | 2025-02-07 |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus | Guangzhou Decheng Biotechnology Co., Ltd. | NGL | Class II | 2025-02-06 |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | Healgen Scientific,, LLC | NGL | Class II | 2024-12-17 |
| K243498 | Alinity c Benzodiazepines Reagent Kit | Microgenics Corporation | JXM | Class II | 2024-12-11 |
| K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test | Eterbio, Inc. | NGL | Class II | 2024-11-20 |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | Hangzhou Clongene Biotech Co., Ltd. | NGL | Class II | 2024-11-08 |
| K240670 | DRI Ecstasy Plus Assay | Microgenics Corporation | DKZ | Class II | 2024-10-30 |
| K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | NGL | Class II | 2024-10-04 |
| K242498 | Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC | Aicheck Biotech, Inc. | NFT | Class II | 2024-10-01 |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NFT | Class II | 2024-09-27 |
| K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel | Qingdao Hightop Biotech Co., Ltd. | NGL | Class II | 2024-08-14 |
| K242077 | PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup | Aicheck Biotech, Inc. | NFT | Class II | 2024-08-14 |
| K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel | Guangzhou Wondfo Biotech Co., Ltd. | NGL | Class II | 2024-07-16 |
| K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | NFT | Class II | 2024-06-17 |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | DJG | Class II | 2024-06-14 |
| K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | NGL | Class II | 2024-05-22 |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) | Healgen Scientific,, LLC | NGL | Class II | 2024-05-13 |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | Guangzhou Decheng Biotechnology Co., Ltd. | DJG | Class II | 2024-05-10 |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific,, LLC | NGL | Class II | 2024-04-12 |
| K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | Safecare Biotech (Hangzhou) Co., Ltd. | NGL | Class II | 2024-04-10 |
| K240295 | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) | Instanosis, Inc. | NGL | Class II | 2024-03-28 |
| K234006 | AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test | Allsource Screening Solutions | NGL | Class II | 2024-03-21 |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | DJG | Class II | 2024-03-08 |
| K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) | Assure Tech., LLC | NGL | Class II | 2024-03-06 |
| K232522 | ARK Levetiracetam II Assay | Ark Diagnostics, Inc. | ORI | Class II | 2024-02-27 |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card | Shanghai Accurature Diagnostics Co., Ltd. | DJG | Class II | 2024-02-23 |
| K233775 | Vivatmo pro | Bosch Healthcare Solutions GmbH | MXA | Class II | 2024-02-22 |
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 | Co-Innovation Biotech Co., Ltd. | LDJ | Class II | 2024-01-17 |
| K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) | Hangzhou Laihe Biotech Co., Ltd. | LDJ | Class II | 2024-01-10 |
| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | Hangzhou Laihe Biotech Co., Ltd. | DJG | Class II | 2024-01-09 |
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test | Chemtron Biotech, Inc. | DJG | Class II | 2023-12-20 |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Guangzhou Decheng Biotechnology Co., Ltd. | DJG | Class II | 2023-12-13 |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx | Hangzhou AllTest Biotech Co., Ltd. | DKZ | Class II | 2023-12-13 |
| K231020 | Alinity c Tricyclic Antidepressants Reagent Kit | Microgenics Corporation | LFH | Class II | 2023-11-17 |
| K231752 | ARK Hydrocodone Assay | Ark Diagnostics, Inc. | DJG | Class II | 2023-11-09 |
| K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | Vivachek Biotech (Hangzhou) Co., Ltd. | NFT | Class II | 2023-11-02 |
| K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | NGL | Class II | 2023-10-26 |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | DJG | Class II | 2023-10-05 |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories Limited | DJG | Class II | 2023-10-05 |
| DEN220023 | Procise ADL | Procisedx, Inc. | QYD | Class II | 2023-09-29 |
| DEN210056 | Procise IFX | Procisedx, Inc. | QXT | Class II | 2023-09-29 |
| K231007 | CEDIA Heroin Metabolite (6-AM) Assay | Microgenics Corporation | DJG | Class II | 2023-09-27 |
| K231978 | BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50 | Vivachek Biotech (Hangzhou) Co., Ltd. | NFW | Class II | 2023-08-31 |
| K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics, Inc. | LEH | Class II | 2023-08-08 |
| K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | DJG | Class II | 2023-07-31 |
| K221605 | Emit® II Plus Buprenorphine Assay | Siemens Healthcare Diagnostics, Inc. | DJG | Class II | 2023-07-25 |
| K213611 | Fenom Pro | Caire Diagnostics, Inc. | MXA | Class II | 2023-06-07 |
| K231137 | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | Xenta Biomedical Science Co., Ltd. | DKZ | Class II | 2023-05-19 |
| K230238 | BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx | Shenzhen Bioeasy Biotechnology Co., Ltd. | DJG | Class II | 2023-03-31 |
| K230161 | ONLINE TDM Phenytoin - Free Phenytoin application | Roche Diagnostics | MOJ | Class II | 2023-03-30 |
| K220026 | Genomadix Cube CYP2C19 System | Genomadix, Inc. | NTI | Class II | 2023-03-21 |
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT | Healgen Scientific,, LLC | LDJ | Class II | 2023-03-17 |
| K222955 | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | Xenta Biomedical Science Co., Ltd. | DJG | Class II | 2023-02-06 |
| K221765 | ONLINE DAT Benzodiazepines II | Roche Diagnostics | JXM | Class II | 2022-12-23 |
| K213875 | DRI TM Tricyclics Serum Tox Assay | Microgenics Corporation | LFH | Class II | 2022-12-21 |
| K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 | Shenzhen Superbio Technology Co., Ltd. | DJG | Class II | 2022-12-13 |
| K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | Vivachek Biotech (Hangzhou) Co., Ltd. | NFT | Class II | 2022-11-10 |
| K221871 | Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx | Healstone Biotech, Inc. | NFT | Class II | 2022-08-30 |
| K203527 | Immunalysis Tapentadol Urine HEIA | Lmmunalysis Corporation | DJG | Class II | 2022-05-09 |
| K220685 | HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx | Qingdao Hightop Biotech Co., Ltd. | NFT | Class II | 2022-05-05 |
| K202644 | Acetaminophen | Sekisui Diagnostics P.E.I., Inc. | LDP | Class II | 2022-02-18 |
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System | Carolina Liquid Chemistries Corp. | DIO | Class II | 2022-01-27 |
| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | DJG | Class II | 2021-12-22 |
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | LAF | Class II | 2021-12-22 |
| K203695 | NObreath® | Bedfont Scientific, Ltd. | MXA | Class II | 2021-12-17 |
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | Psychemedics Corporation | LAF | Class II | 2021-12-15 |
| K211973 | DRI Cocaine Metabolite Assay | Microgenics Corporation | DIO | Class II | 2021-09-24 |
| K211667 | Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) | Changzhou Universal Medical Equipment Co., Ltd. | LAZ | Class I | 2021-09-23 |
| K210858 | VITROS Chemistry Products PHBR Slides | Ortho-Clinical Diagnostics, Inc. | DLZ | Class II | 2021-08-13 |
| K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | DJG | Class II | 2021-08-12 |
3,041 clearances in the Clinical Toxicology panel. Data: openFDA.