510(k) K002290 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
| Applicant | Radiometer Medical A/S, Bronshoj, DK |
| Decision | Substantially Equivalent, Sep 13, 2000 |
| Received | Jul 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002290
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2013 | Radiometer America Inc Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood. Terminated |
KHP | None listed |
| 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 |
| Jul 15, 2009 | Radiometer America Inc Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513.
The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing. Terminated |
CHL | None listed |
| Dec 3, 2008 | Radiometer America Inc ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024
Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lacta Terminated |
JFP | None listed |
| Jan 18, 2008 | Radiometer America Inc ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device). Terminated |
CHL | None listed |
| Jul 24, 2007 | Radiometer America Inc ABL 700 Series blood gas analyzers equipped with Software Version 3.833. 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.