510(k) K964308 ยท KHQ Radioassay, Triiodothyronine Uptake
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Nov 27, 1996 |
| Received | Oct 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964308
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.