The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Cocaine Metabolite Eia Test.
| Device ID | K915371 |
| 510k Number | K915371 |
| Device Name: | COCAINE METABOLITE EIA TEST |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | DIAGNOSTIC REAGENTS, INC. 3255-4 SCOTT BLVD. SUITE 102 Santa Clara, CA 95054 |
| Contact | Yuh-geng Tsay |
| Correspondent | Yuh-geng Tsay DIAGNOSTIC REAGENTS, INC. 3255-4 SCOTT BLVD. SUITE 102 Santa Clara, CA 95054 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-27 |
| Decision Date | 1991-12-18 |