510(k) K972133 ยท JLS Radioimmunoassay, Progesterone
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jun 24, 1997 |
| Received | Jun 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972133
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.