The following data is part of a premarket notification filed by Cozart Bioscience Ltd. with the FDA for Cozart Eia Opiates Oral Fluid Kit.
| Device ID | K024339 |
| 510k Number | K024339 |
| Device Name: | COZART EIA OPIATES ORAL FLUID KIT |
| Classification | Cholinesterase Test Paper |
| 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 | DIG |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-27 |
| Decision Date | 2003-04-07 |