510(k) K951595 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Sep 8, 1995 |
| Received | Apr 6, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951595
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2021 | Roche Diagnostics Operations, Inc. IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi Open, Classified |
JJE | None listed |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. Roche COBAS INTEGRA 800 /800 CTS Analyzer
Analyzer, Chemistry (Photometric, Discrete for Clinical use
Product Usage:
The system cobas p612 is a computer-controlled stand-alone system for aliquoting a Terminated |
JJE | None listed |
| Nov 5, 2013 | Roche Diagnostics Operations, Inc. COBAS INTEGRA 800 Analyzer with software 9864.C2
Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling access Terminated |
JJE | None listed |
| Jan 18, 2013 | Roche Diagnostics Operations, Inc. Roche COBAS INTEGRA 400 and 400 plus Analyzer,
an in vitro diagnostic analyzer. Terminated |
JJE | None listed |
| Oct 9, 2008 | Roche Diagnostics Corp. Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122.
An in-vitro diagnostic reagent system intended for use on COBAS Integra system Terminated |
JIY | None listed |
| Oct 9, 2008 | Roche Diagnostics Corp. Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322.
An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for t Terminated |
CGX | None listed |
| Mar 21, 2003 | Roche Diagnostics Corp. COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345 Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.