The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Free Thyroxine(ft4) Assay.
| Device ID | K925177 |
| 510k Number | K925177 |
| Device Name: | VIDAS FREE THYROXINE(FT4) ASSAY |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
| Contact | Vicki Anastasi |
| Correspondent | Vicki Anastasi BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-14 |
| Decision Date | 1992-11-30 |