510(k) K984166 ยท CGN Acid, Folic, Radioimmunoassay
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Feb 5, 1999 |
| Received | Nov 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984166
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 Open, Classified |
CGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.