The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Methaqualone Enzyme Immunoassay.
| Device ID | K940123 |
| 510k Number | K940123 |
| Device Name: | METHAQUALONE ENZYME IMMUNOASSAY |
| Classification | Radioimmunoassay, Methaqualone |
| Applicant | DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Contact | Yuh-geng Tsaym Ph.d. |
| Correspondent | Yuh-geng Tsaym Ph.d. DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Product Code | KXS |
| CFR Regulation Number | 862.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-10 |
| Decision Date | 1994-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883003415 | K940123 | 000 |
| 00884883002937 | K940123 | 000 |