510(k) K111188 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, May 14, 2012 |
| Received | Apr 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111188
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2017 | Roche Diagnostics Operations, Inc. Cobas b 123 POC system
The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), m Terminated |
CHL | None listed |
| Aug 21, 2015 | Roche Diagnostics Operations, Inc. cobas b 123 Fluid Pack COOX REF 05169992001 200
Product Usage:
The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes N Terminated |
CHL | None listed |
| Aug 21, 2015 | Roche Diagnostics Operations, Inc. cobas b 123 Fluid Pack COOX REF 05170036001 400
Product Usage:
The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes N Terminated |
CHL | None listed |
| Dec 13, 2012 | Roche Diagnostics Operations, Inc. Cobas b 123 POC system
cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolit Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.