The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Cocaine Metabolite Eia Assay Modification.
| Device ID | K935016 |
| 510k Number | K935016 |
| Device Name: | COCAINE METABOLITE EIA ASSAY MODIFICATION |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Contact | Yeh-geng Tsay |
| Correspondent | Yeh-geng Tsay DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-18 |
| Decision Date | 1993-12-03 |