510(k) K043218 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
| Applicant | Radiometer Medical Aps, Bronshoj, DK |
| Decision | Substantially Equivalent, May 10, 2005 |
| Received | Nov 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043218
| 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 |
| Jun 16, 2011 | Radiometer America Inc Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) me Terminated |
JFP | None listed |
| Apr 6, 2007 | Radiometer America Inc ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27 Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.