510(k) K033009 ยท CIX Bromcresol Green Dye-Binding, Albumin
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 16, 2003 |
| Received | Sep 26, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033009
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2020 | Roche Diagnostics Operations, Inc. Albumin Gen.2, Catalog 05166861190 Terminated |
CIX | None listed |
| Oct 16, 2019 | Roche Diagnostics Operations, Inc. Roche Diagnostics cobas Integra Albumin Gen.2
Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi co Terminated |
CIX | None listed |
| Oct 9, 2008 | Roche Diagnostics Corp. Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04469658190.
An in-vitro diagnostic reagent system intended for use on COBAS Terminated |
CIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.