510(k) K970643 ยท CHP Radioimmunoassay, Estradiol
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Mar 18, 1997 |
| Received | Feb 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970643
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2016 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF3 Terminated |
CHP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.