510(k) K964720 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Feb 4, 1997 |
| Received | Nov 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964720
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2022 | Ortho-Clinical Diagnostics, Inc VITROS Immunodiagnostic Products FSH Reagent Pack- IVD
1931922 Open, Classified |
CGJ | None listed |
| Jul 12, 2018 | Ortho Clinical Diagnostics Inc VITROS Immunodiagnostic Products - FSH Reagent Pack
(10758750000302) 1931922 Open, Classified |
CGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.