The following data is part of a premarket notification filed by Serex, Inc. with the FDA for Automates Coma Cocaine Metabolite Assay.
| Device ID | K921834 |
| 510k Number | K921834 |
| Device Name: | AUTOMATES COMA COCAINE METABOLITE ASSAY |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | SEREX, INC. 230 WEST PASSAIC ST. Maywood, NJ 07607 |
| Contact | Victor Lee-own |
| Correspondent | Victor Lee-own SEREX, INC. 230 WEST PASSAIC ST. Maywood, NJ 07607 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-16 |
| Decision Date | 1992-06-15 |