510(k) K964982 ยท CEP Radioimmunoassay, Luteinizing Hormone
VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Feb 20, 1997 |
| Received | Dec 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964982
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2022 | Ortho-Clinical Diagnostics, Inc VITROS Immunodiagnostic Products LH Reagent Pack
Product Code: 1350198 Open, Classified |
CEP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.