The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vitek Immunodiagnostic Assay System.
| Device ID | K921746 |
| 510k Number | K921746 |
| Device Name: | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM |
| Classification | Radioimmunoassay, Follicle-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 | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-13 |
| Decision Date | 1992-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026156947 | K921746 | 000 |