Cleared Traditional

ABL90 FLEX PLUS System

K241037 · Radiometer Medicals Aps · Chemistry

Jan 2025

Decision

273d

Days

Class 2

Risk

About This 510(k) Submission

K241037 is an FDA 510(k) clearance for the ABL90 FLEX PLUS System, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Radiometer Medicals Aps (Br?nsh?j, DK). The FDA issued a Cleared decision on January 14, 2025, 273 days after receiving the submission on April 16, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number	K241037 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 16, 2024
Decision Date	January 14, 2025
Days to Decision	273 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF