K-number	K252357
Device name	Glucose2
Applicant	Abbott Ireland
Product code	CFR
Device class	Class II
Decision date	Oct 24, 2025
Decision	Substantially Equivalent
Regulation	862.1345

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Glucose2

Everything you need for a 510(k) submission. Nothing you don't.