The following data is part of a premarket notification filed by Cozart Bioscience Ltd. with the FDA for Cozart Eia Cotinine Urine Kit.
| Device ID | K021944 |
| 510k Number | K021944 |
| Device Name: | COZART EIA COTININE URINE KIT |
| Classification | Enzyme Immunoassay, Nicotine And Nicotine Metabolites |
| Applicant | COZART BIOSCIENCE LTD. 45 MILTON PARK ABINGDON Oxfordshire Ox14 4ru, GB Ox14 4ru |
| Contact | Roberto Liddi |
| Correspondent | Roberto Liddi COZART BIOSCIENCE LTD. 45 MILTON PARK ABINGDON Oxfordshire Ox14 4ru, GB Ox14 4ru |
| Product Code | MKU |
| CFR Regulation Number | 862.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-13 |
| Decision Date | 2003-05-14 |
| Summary: | summary |