510(k) K983031 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 18, 1998 |
| Received | Aug 31, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983031
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2016 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: th Terminated |
LOJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.