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510(k) K252488

ABL90 FLEX PLUS System by Radiometer Medicals Aps — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2026
Date Received
August 8, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Radiometer Medicals Aps

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  • K240998 — ABL90 FLEX PLUS System (December 13, 2024)

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