Biolinq Shine Autonomous Time-in-Range Microsensor
FDA 510(k) clearance DEN240080 · decided 2025-09-23
Clearance details
- K-number
- DEN240080
- Device name
- Biolinq Shine Autonomous Time-in-Range Microsensor
- Applicant
- Biolinq Incorporated
- Decision
- Unknown
- Date received
- 2024-12-27
- Decision date
- 2025-09-23
- Days to decision
- 270 days
- Clearance type
- Direct
- Product code
- SFU
- Device class
- 2
- Regulation number
- 862.1359
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.