510(k) K071211 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
COBAS C 111 ANALYZER
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 30, 2007 |
| Received | May 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071211
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2016 | Roche Diagnostics Operations, Inc. Roche COBAS INTEGRA c111
Analyzer, Chemistry (Photometric, Discrete), for clinical use
Product Usage:
The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing cl Terminated |
JJE | None listed |
| Nov 30, 2011 | Roche Diagnostics Operations, Inc. Roche Cobas c 111 Analyzer
The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured pho Terminated |
JJE | None listed |
| Mar 24, 2009 | Roche Diagnostics Corp. Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN.
Is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific pro Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.