FDA.report

510(k) K252488

Device
ABL90 FLEX PLUS System
Applicant
Radiometer Medicals Aps
510(k) number
K252488
Product code
CGA
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-01
Date received
2025-08-08
Regulation
862.1345
Classification name
Glucose Oxidase, Glucose
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Andrea Swingle
Address
Åkandevej Brønshøj DK 2700 2700

FDA Registration Numbers

Source Documents

510(k) summary PDF

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