| K240670 | microgenics corporation | DRI Ecstasy Plus Assay | October 30, 2024 |
| K233019 | hangzhou alltest biotech co | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest | December 13, 2023 |
| K231137 | xenta biomedical science co | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | May 19, 2023 |
| K200363 | quidel cardiovascular | Quidel Triage® TOX Drug Screen, 94600 | March 11, 2020 |
| K191099 | atlas medical | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel | October 3, 2019 |
| K182719 | quidel cardiovascular | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | June 19, 2019 |
| K182738 | hangzhou alltest biotech co | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Mul | March 27, 2019 |
| K180879 | shanghai venture bio-tech co | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi- | December 14, 2018 |
| K181945 | phamatech | QuickScreen Pro Multi Drug Screening Test, Model 9395Z | October 18, 2018 |
| K173303 | alfa scientific designs | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT | February 23, 2018 |
| K161251 | hangzhou clongene biotech co | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests | August 30, 2016 |
| K152122 | alfa scientific designs | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine | June 24, 2016 |
| K152908 | ucp biosciences | UCP COMPACT DRUG TESTS | May 3, 2016 |
| K152590 | coretests | ACCU NEWS Drug Screening Test Card/Urine Cup | April 15, 2016 |
| K153465 | assure tech. (hangzhou) co | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), A | March 31, 2016 |
| K152269 | healgen scientific | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test | September 9, 2015 |
| K151213 | ucp biosciences | UCP Drug Test Mini Cups | August 21, 2015 |
| K142855 | omega laboratories | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-me | July 28, 2015 |
| K141748 | biophor diagnostics | RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CAL | May 20, 2015 |
| K143500 | immunalysis corporation | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine | February 6, 2015 |