510(k) K032311 ยท CEM Electrode, Ion Specific, Potassium
ROCHE DIAGNOSTICS OMNI S ANALYZER
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 17, 2003 |
| Received | Jul 28, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032311
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2018 | Roche Diagnostics Corporation cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measuremen Terminated |
CEM | None listed |
| May 3, 2018 | Roche Diagnostics Corporation Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurem Terminated |
CEM | None listed |
| May 3, 2018 | Roche Diagnostics Corporation cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measureme Terminated |
CEM | None listed |
| May 3, 2018 | Roche Diagnostics Corporation cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measuremen Terminated |
CEM | None listed |
| Oct 31, 2016 | Roche Diagnostics Operations, Inc. MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the
Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to Terminated |
CDS | None listed |
| Aug 5, 2015 | Roche Diagnostics Operations, Inc. S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184
Blood Gas and Electrolytes Analyzer; The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to Terminated |
CHL | None listed |
| Feb 2, 2015 | Roche Diagnostics Operations, Inc. Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer Terminated |
CGA | None listed |
| Oct 10, 2014 | Roche Diagnostics Operations, Inc. Omni Micro-electrode/reference electrode for cobas b221 analyzer.
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2 Terminated |
CHL | None listed |
| Apr 2, 2014 | Roche Diagnostics Operations, Inc. Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number:
03111873180 as a part of the following systems:
1. 03337103001, cobas b 221<1>Roche OMNI S1 system
2. 033 Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.