The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Amphetamines Eia Test.
| Device ID | K921554 |
| 510k Number | K921554 |
| Device Name: | AMPHETAMINES EIA TEST |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Contact | Yuh-geng Tsay |
| Correspondent | Yuh-geng Tsay DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-01 |
| Decision Date | 1992-05-04 |