COZART EIA COTININE URINE KIT
FDA 510(k) clearance K021944 · decided 2003-05-14
Clearance details
- K-number
- K021944
- Device name
- COZART EIA COTININE URINE KIT
- Applicant
- Cozart Bioscience , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-13
- Decision date
- 2003-05-14
- Days to decision
- 335 days
- Clearance type
- Traditional
- Product code
- MKU
- Device class
- 1
- Regulation number
- 862.3220
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Oxfordshire Ox14 4ru, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.