510(k) K964721 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 18, 1996 |
| Received | Nov 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964721
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2016 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics,
For in vitro diagnostic use only. For th Terminated |
KLI | None listed |
| Jun 21, 2005 | Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK. Terminated |
KLI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.