510(k) K965142 ยท CEC Radioimmunoassay, Free Thyroxine
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Mar 18, 1997 |
| Received | Dec 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965142
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.