ABL90 FLEX PLUS System— 510(k) K241037

Substantially Equivalent

Radiometer Medicals Aps

FDA 510(k) clearance K241037 for ABL90 FLEX PLUS System, Substantially Equivalent on 2025-01-14. Applicant: Radiometer Medicals Aps. Device class: 2.

Clearance details

Applicant: Radiometer Medicals Aps
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 2024-04-16
Decision date: 2025-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brønshøj, DK

Download summary PDF View on FDA.gov ↗

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More clearances from Radiometer Medicals Aps

K252475 — ABL90 FLEX PLUS System2026-05-01
K252488 — ABL90 FLEX PLUS System2026-05-01
K252207 — ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
K240998 — ABL90 FLEX PLUS System2024-12-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.