The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Methadone Enzyme Immunoassay.
| Device ID | K934667 |
| 510k Number | K934667 |
| Device Name: | METHADONE ENZYME IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Methadone |
| 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 | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-29 |
| Decision Date | 1994-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740005504 | K934667 | 000 |