ABL90 FLEX— 510(k) K120197
Substantially EquivalentRadiometer Medical Aps
FDA 510(k) clearance K120197 for ABL90 FLEX, Substantially Equivalent on 2012-03-19. Applicant: Radiometer Medical Aps. Device class: 2.
Clearance details
- Applicant
- Radiometer Medical Aps
- Product code
- Code CHL
- Device class
- Class 2
- Regulation
- 21 CFR 862.1120
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Broenshoej, DK
Recent devices under product code CHL
view allMore clearances from Radiometer Medical Aps
view allAdverse events under product code CHL
product code CHL- Death
- 20
- Malfunction
- 999
- Total
- 1,019
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K120197
K-number listed on FDA's recall record- Z-0010-2019 — 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 oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.
- Z-1046-2015 — 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.
- Z-2164-2012 — ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120197.
Data sourced from openFDA. This site is unofficial and independent of the FDA.