The following data is part of a premarket notification filed by Cozart Bioscience Ltd. with the FDA for Cozart Rapiscan Oral Fluid Drug Test - Opiate/methadone.
| Device ID | K020920 |
| 510k Number | K020920 |
| Device Name: | COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-21 |
| Decision Date | 2002-11-05 |
| Summary: | summary |