510(k) K970281 ยท CFT Radioimmunoassay, Prolactin (Lactogen)
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Feb 25, 1997 |
| Received | Jan 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970281
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2022 | Ortho-Clinical Diagnostics, Inc VITROS Immunodiagnostic Products Prolactin Reagent Pack
Product Code: 1849793 Open, Classified |
CFT | None listed |
| Jul 12, 2018 | Ortho Clinical Diagnostics Inc VITROS Immunodiagnostic Products - Prolactin Reagent Pack
(10758750000111) 1849793 Open, Classified |
CFT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.