The following data is part of a premarket notification filed by Serex, Inc. with the FDA for Coma Cocaine Metabolite Assay (eia).
| Device ID | K895043 |
| 510k Number | K895043 |
| Device Name: | COMA COCAINE METABOLITE ASSAY (EIA) |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | SEREX, INC. 38 FRANKLIN ST. Tenafly, NJ 07670 |
| Contact | Fitzpatrick-davis |
| Correspondent | Fitzpatrick-davis SEREX, INC. 38 FRANKLIN ST. Tenafly, NJ 07670 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-09 |
| Decision Date | 1989-11-08 |