The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Thyroxine Enzyme Immunoassay.
| Device ID | K944703 |
| 510k Number | K944703 |
| Device Name: | THYROXINE ENZYME IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| 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 | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-23 |
| Decision Date | 1994-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883004177 | K944703 | 000 |
| 00884883003446 | K944703 | 000 |