The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Vidas Ft4.
| Device ID | K132058 |
| 510k Number | K132058 |
| Device Name: | VIDAS FT4 |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | BIOMERIEUX SA 5 RUE DES AQUEDUCS Craponne, FR 69290 |
| Contact | Aurelie Permezel |
| Correspondent | Aurelie Permezel BIOMERIEUX SA 5 RUE DES AQUEDUCS Craponne, FR 69290 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-03 |
| Decision Date | 2015-06-08 |
| Summary: | summary |