The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Opiate Eia Assay.
| Device ID | K915180 |
| 510k Number | K915180 |
| Device Name: | OPIATE EIA ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-15 |
| Decision Date | 1992-01-22 |