Name: Predicase
Price: 199 USD

K-number	DEN240080
Device name	Biolinq Shine Autonomous Time-in-Range Microsensor
Applicant	Biolinq Incorporated
Product code	SFU
Device class	Class II
Decision date	Sep 23, 2025
Decision	Not Substantially Equivalent
Regulation	862.1359

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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Biolinq Shine Autonomous Time-in-Range Microsensor

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