Cleared Traditional

Glucose2

K252357 · Abbott Ireland · Chemistry
Oct 2025
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K252357 is an FDA 510(k) clearance for the Glucose2, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Abbott Ireland (Longford, IE). The FDA issued a Cleared decision on October 24, 2025, 87 days after receiving the submission on July 29, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K252357 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2025
Decision Date October 24, 2025
Days to Decision 87 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CFR — Hexokinase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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