510(k) K992859 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
| Applicant | Radiometer America, Inc., Westlake OH, US |
| Decision | Substantially Equivalent, Jan 10, 2000 |
| Received | Aug 25, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K992859
| 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 |
| Aug 10, 2006 | Radiometer America Inc Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004. Terminated |
JFP | None listed |
| Aug 2, 2006 | Radiometer America Inc Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series. Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.