MKU
7 FDA 510(k) clearances · Product code
173 daysmedian time to decision
335 days90th percentile
7clearances measured
FDA profile
- Official device name
- Enzyme Immunoassay, Nicotine And Nicotine Metabolites
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3220
- Medical specialty
- Clinical Toxicology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Psychemedics Microplate EIA for Cotinine in Hair (K192517) | Psychemedics Corporation | 2020-04-22 |
| LZI Cotinine II Enzyme Immunoassay (K192299) | Lin-Zhi International, Inc. | 2019-11-21 |
| STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE (K062565) | Princeton BioMeditech Corp. | 2007-02-20 |
| COZART EIA COTININE URINE KIT (K021944) | Cozart Bioscience , Ltd. | 2003-05-14 |
| MICRO-PLATE COTININE EIA (K974534) | OraSure Technologies, Inc. | 1998-05-18 |
| MICRO-PLATE COTININE EIA (K974234) | OraSure Technologies, Inc. | 1998-05-14 |
| AUTO-LYTE COTININE EIA (K972481) | OraSure Technologies, Inc. | 1997-10-21 |
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Every clearance here is in the API, with alerts when new ones post.