DEN240080
- 510(k) number
- DEN240080
- Device name
- Biolinq Shine Autonomous Time-in-Range Microsensor
- Applicant
- Biolinq Incorporated CA · US
- Product code
- SFU — Glucose Range Monitoring System
- Decision date
- 2025-09-23
- Date received
- 2024-12-27
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Clinical Chemistry
Official FDA record: DEN240080
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.