The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Propoxphene Eia Test.
| Device ID | K943414 |
| 510k Number | K943414 |
| Device Name: | PROPOXPHENE EIA TEST |
| Classification | Enzyme Immunoassay, Propoxyphene |
| 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 | JXN |
| CFR Regulation Number | 862.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-15 |
| Decision Date | 1994-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740011536 | K943414 | 000 |
| 00884883012899 | K943414 | 000 |
| 00884883003439 | K943414 | 000 |
| 00884883002975 | K943414 | 000 |
| 00380740165307 | K943414 | 000 |