Glucose2— 510(k) K252357

Substantially Equivalent

Abbott Ireland

FDA 510(k) clearance K252357 for Glucose2, Substantially Equivalent on 2025-10-24. Applicant: Abbott Ireland. Device class: 2.

Clearance details

Applicant
Abbott Ireland
Product code
Code CFR
Device class
Class 2
Regulation
21 CFR 862.1345
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Longford, IE
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