510(k) K003064 ยท DDG Transferrin, Antigen, Antiserum, Control
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 1, 2001 |
| Received | Oct 2, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003064
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2019 | Roche Diagnostics Operations, Inc. cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay
Catalog Number: 20763454122 Terminated |
DDG | None listed |
| Aug 28, 2019 | Roche Diagnostics Operations, Inc. cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay
Catalog Number: 05950821190 Terminated |
DDG | None listed |
| Oct 9, 2008 | Roche Diagnostics Corp. Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 20763454122.
An in-vitro diagnostic reagent system intended for u Terminated |
DDG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.