510(k) K252475

Device
ABL90 FLEX PLUS System
Applicant
Radiometer Medicals Aps
510(k) number
K252475
Product code
JGS
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-01
Date received
2025-08-07
Regulation
862.1665
Classification name
Electrode, Ion Specific, Sodium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Andrea Swingle
Address
Åkandevej Brønshøj DK 2700 2700

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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