K241037
- 510(k) number
- K241037
- Device name
- ABL90 FLEX PLUS System
- Applicant
- Radiometer Medicals Aps DK
- Product code
- CEM — Electrode, Ion Specific, Potassium
- Decision date
- 2025-01-14
- Date received
- 2024-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241037.pdf
Official FDA record: K241037
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.