510(k) K921746 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Jun 16, 1992 |
| Received | Apr 13, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921746
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2018 | BioMerieux SA VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France.
For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitati Terminated |
CGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.