| K240670 | DRI Ecstasy Plus Assay | Microgenics Corporation | 2024-10-30 |
| 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. | 2023-12-13 |
| K231137 | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | Xenta Biomedical Science Co., Ltd. | 2023-05-19 |
| K200363 | Quidel Triage® TOX Drug Screen, 94600 | Quidel Cardiovascular, Inc. | 2020-03-11 |
| K191099 | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel | Atlas Medical | 2019-10-03 |
| K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | Quidel Cardiovascular, Inc. | 2019-06-19 |
| K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug R... | Hangzhou AllTest Biotech Co., Ltd. | 2019-03-27 |
| K180879 | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use | Shanghai Venture Bio-Tech Co., Ltd. | 2018-12-14 |
| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395Z | Phamatech, Inc. | 2018-10-18 |
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) | Alfa Scientific Designs, Inc. | 2018-02-23 |
| K161251 | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests | Hangzhou Clongene Biotech Co., Ltd. | 2016-08-30 |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) | Alfa Scientific Designs, Inc. | 2016-06-24 |
| K152908 | UCP COMPACT DRUG TESTS | Ucp Biosciences, Inc. | 2016-05-03 |
| K152590 | ACCU NEWS Drug Screening Test Card/Urine Cup | Coretests, Inc. | 2016-04-15 |
| K153465 | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) | Assure Tech. (Hangzhou) Co, Ltd. | 2016-03-31 |
| K152269 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) | Healgen Scientific,, LLC | 2015-09-09 |
| K151213 | UCP Drug Test Mini Cups | Ucp Biosciences, Inc. | 2015-08-21 |
| K142855 | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) | Omega Laboratories, Inc. | 2015-07-28 |
| K141748 | RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET | Biophor Diagnostics, Inc. | 2015-05-20 |
| K143500 | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set | Immunalysis Corporation | 2015-02-06 |
| K142800 | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2014-12-11 |
| K142580 | Chemtrue Multi-Panel DOA DIP Card Tests | Chemtron Biotech, Inc. | 2014-12-01 |
| K141532 | CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE | Guangzhou Wondfo Biotech Co., Ltd. | 2014-07-14 |
| K131069 | QUICKSCREEN AMPHETINE 500 TEST | Phamatech, Inc. | 2014-05-14 |
| K132812 | UCP MULTI-DRUG TEST KEY CUPS | Ucp Biosciences, Inc. | 2014-03-06 |
| K133968 | WONDFO MULTI-DRUG URINE TEST CUP, PANEL | Guangzhou Wondfo Biotech Co., Ltd. | 2014-02-25 |
| K131653 | LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | Lin-Zhi International, Inc. | 2014-02-04 |
| K131110 | ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD | Co-Innovation Biotech Co., Ltd. | 2014-01-15 |
| K130082 | GENPRIME DRUGS OF ABUSE READER SYSTEM | Genprime, Inc. | 2013-12-20 |
| K131645 | INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) | Alfa Scientific Designs, Inc. | 2013-10-07 |