510(k) K964310 ยท CDP Radioimmunoassay, Total Triiodothyronine
VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Nov 27, 1996 |
| Received | Oct 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964310
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2015 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales Terminated |
CDP | None listed |
| Apr 20, 2006 | Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than Terminated |
CDP | None listed |
| Feb 21, 2003 | Ortho-Clinical Diagnostics Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793 Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.