510(k) K120197 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL90 FLEX
| Applicant | Radiometer Medical Aps, Broenshoej, DK |
| Decision | Substantially Equivalent, Mar 19, 2012 |
| Received | Jan 23, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120197
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2018 | Radiometer America Inc ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oxim Terminated |
JJE | None listed |
| Feb 9, 2015 | Radiometer America Inc ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. Terminated |
JJE | None listed |
| Aug 8, 2012 | Radiometer America Inc ABL90 FLEX software version 2.7 MR3.
The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood. Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.