The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Thyroxine (t4) Assay (t4).
| Device ID | K926393 |
| 510k Number | K926393 |
| Device Name: | VIDAS THYROXINE (T4) ASSAY (T4) |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Vickie Anastasi |
| Correspondent | Vickie Anastasi BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-21 |
| Decision Date | 1993-05-13 |