Class Class II

Biolinq Shine Autonomous Time-in-Range Microsensor (DEN240080)

DEN240080 2025-09-23 Direct
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Description

Biolinq Shine Autonomous Time-in-Range Microsensor by Biolinq Incorporated, an FDA 510(k) cleared clinical chemistry device.

Regulatory Information

Device ClassClass Class II
510(k) NumberDEN240080
Clearance Date2025-09-23
Clearance TypeDirect
Product CodeSFU
Regulation Number862.1359

Categories

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