The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Phenytion Eia Test.
| Device ID | K945725 |
| 510k Number | K945725 |
| Device Name: | PHENYTION EIA TEST |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Contact | Yuh-gen Tsay |
| Correspondent | Yuh-gen Tsay DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-22 |
| Decision Date | 1995-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740135515 | K945725 | 000 |
| 00380740102708 | K945725 | 000 |