510(k) K921816 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Jun 18, 1992 |
| Received | Apr 15, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921816
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.