510(k) K100777 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL837 FLEX ANALYZER
| Applicant | Radiometer Medical Aps, Bronshoj, DK |
| Decision | Substantially Equivalent, Dec 10, 2010 |
| Received | Mar 18, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K100777
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2012 | Radiometer America Inc The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of:
-Samples of whole blood for the parameters pH, pO2, pCO2,
cK+, cNa+, cCa2+, cCl, cGlu, c Terminated |
CHL | None listed |
| Aug 8, 2012 | Radiometer America Inc The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of:
-Samples of whole blood for the parameters pH, pO2, pCO2,
cK+, cNa+, cCa2+, c Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.