Biolinq Shine Autonomous Time-in-Range Microsensor

• K Number: DEN240080
• Device Name: Biolinq Shine Autonomous Time-in-Range Microsensor
• Manufacturer: Biolinq Incorporated
• Date Cleared: 2025-09-23 ( 270 days)
• Product Code: SFU
• Regulation Number: 862.1359
• Type: Direct
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

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