The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vitek Immun Assay Sys(vidas) Thyroi Stim Hor Assay.
| Device ID | K921816 |
| 510k Number | K921816 |
| Device Name: | VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Vicki Anastasi |
| Correspondent | Vicki Anastasi BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-15 |
| Decision Date | 1992-06-18 |