510(k) K051968 ยท CGL Electrode, Ion Based, Enzymatic, Creatinine
ABL8X7 FLEX
| Applicant | Radiometer Medical Aps, Bronshoj, DK |
| Decision | Substantially Equivalent, Oct 16, 2006 |
| Received | Jul 20, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051968
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2018 | Radiometer America Inc Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837.
ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, Terminated |
CHL | None listed |
| Mar 18, 2015 | Radiometer America Inc Crea A and B membranes, packaged 4 per box
Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2 Terminated |
CGL | None listed |
| Feb 13, 2012 | Radiometer America Inc S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark
Product Usage:
The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 s Terminated |
CGL | None listed |
| Mar 5, 2010 | Radiometer America Inc Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box. Terminated |
CGL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.