510(k) clearance
Biolinq Shine Autonomous Time-in-Range Microsensor
- 510(k) number
- K262599
- Applicant
- Biolinq Incorporated
- Decision date
- Sep 18, 2026
- Date received
- Jul 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- SFU
- Device type
- Glucose Range Monitoring System
- Device class
- Class II
- Regulation
- 21 CFR 862.1359
- Advisory committee
- Clinical Chemistry
- Statement or summary
- Summary
- Third party
- N
- Location
- San Diego, CA, US