The following data is part of a premarket notification filed by Cozart Bioscience Ltd. with the FDA for Cozart Eia Cocaine Oral Fliud Kit.
| Device ID | K030234 |
| 510k Number | K030234 |
| Device Name: | COZART EIA COCAINE ORAL FLIUD KIT |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | COZART BIOSCIENCE LTD. 45 MILTON PARK Abingdon, Oxon, GB Ox14 4ru |
| Contact | Roberto Liddi |
| Correspondent | Roberto Liddi COZART BIOSCIENCE LTD. 45 MILTON PARK Abingdon, Oxon, GB Ox14 4ru |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-23 |
| Decision Date | 2003-04-28 |
| Summary: | summary |