Clearance Summary
Biolinq Shine Autonomous Time-in-Range Microsensor received FDA 510(k) clearance under submission number DEN240080, sponsored by Biolinq Incorporated. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2025-09-23.
- Submission: DEN240080
- Applicant / Sponsor: Biolinq Incorporated
- Clearance pathway: Direct
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1359
- Decision date: 2025-09-23
Classification & Regulation
This clearance is catalogued under FDA product code SFU and 21 CFR 862.1359, within the Clinical Chemistry review panel as a Class II device.