510(k) K964558 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 16, 1996 |
| Received | Nov 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964558
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.