K252488
- 510(k) number
- K252488
- Device name
- ABL90 FLEX PLUS System
- Applicant
- Radiometer Medicals Aps DK
- Product code
- CGA — Glucose Oxidase, Glucose
- Decision date
- 2026-05-01
- Date received
- 2025-08-08
- 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: K252488.pdf
Official FDA record: K252488
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.