Biolinq Shine Autonomous Time-in-Range Microsensor— 510(k) DEN240080

Name: FDA 510(k) clearance DEN240080
Creator: U.S. Food and Drug Administration
Published: 2025-09-23

Unknown

Biolinq Incorporated

FDA 510(k) clearance DEN240080 for Biolinq Shine Autonomous Time-in-Range Microsensor, Unknown on 2025-09-23. Applicant: Biolinq Incorporated. Device class: 2.

Clearance details

Applicant: Biolinq Incorporated
Product code: Code SFU
Device class: Class 2
Regulation: 21 CFR 862.1359
Advisory panel: Clinical Chemistry
Date received: 2024-12-27
Decision date: 2025-09-23
Decision: Unknown
Clearance type: Direct
Location: San Diego, CA, US

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