510(k) K092686 ยท CEM Electrode, Ion Specific, Potassium
ABL90 FLEX SERIES
| Applicant | Radiometer Medical Aps, Bronshoj, DK |
| Decision | Substantially Equivalent, Aug 6, 2010 |
| Received | Sep 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092686
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2025 | Radiometer Medical ApS Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090
Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092
The Radiometer ABL90 Series is a portable, automated an Open, Classified |
CHL | None listed |
| Apr 14, 2021 | Radiometer Medical ApS Radiometer ABL90 FLEX Analyzer with E3800 PC units.
The E3800 CPU is also used as spare part. Open, Classified |
CEM | None listed |
| Apr 14, 2021 | Radiometer Medical ApS E3800 PC Units (spare parts) Open, Classified |
CEM | None listed |
| Feb 3, 2020 | Radiometer Medical ApS ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. Terminated |
CEM | None listed |
| Nov 21, 2019 | Radiometer Medical ApS ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intende Terminated |
CHL | None listed |
| Aug 22, 2019 | Radiometer America Inc ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 Terminated |
CEM | None listed |
| Jan 26, 2017 | Radiometer America Inc ABL90 Flex
Model #: 393-090
Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood. Terminated |
CHL | None listed |
| Jan 23, 2014 | Radiometer America Inc ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21
Brnshj, Denmark
A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole b Terminated |
JGS | None listed |
| Apr 28, 2011 | Radiometer America Inc ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall.
The Terminated |
CEM | None listed |
| Feb 2, 2011 | Radiometer America Inc ABL90 FLEX Blood Analyzer Part Number: 393-090.
Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care se Terminated |
CEM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.