The following data is part of a premarket notification filed by Cozart Bioscience Ltd. with the FDA for Cozart Eia Amphetamines Oral Fluid Microplate Kit.
| Device ID | K033743 |
| 510k Number | K033743 |
| Device Name: | COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT |
| Classification | Infusor, Pressure, For I.v. Bags |
| Applicant | COZART BIOSCIENCE LTD. 45 MILTON PARK Abingdon,oxfordshire, GB Ox14 4ru |
| Contact | Roberto Liddi |
| Correspondent | Roberto Liddi COZART BIOSCIENCE LTD. 45 MILTON PARK Abingdon,oxfordshire, GB Ox14 4ru |
| Product Code | KZD |
| CFR Regulation Number | 880.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-28 |
| Decision Date | 2004-06-03 |
| Summary: | summary |