510(k) DEN240080
- Device
- Biolinq Shine Autonomous Time-in-Range Microsensor
- Applicant
- Biolinq Incorporated
- 510(k) number
- DEN240080
- Product code
- SFU
- Decision
- Unknown (DENG)
- Decision date
- 2025-09-23
- Date received
- 2024-12-27
- Regulation
- 862.1359
- Classification name
- Glucose Range Monitoring System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Kate Hunter
- Address
- 10260 Sorrento Valley Rd. San Diego CA US 92121 92121
FDA Registration Numbers
- 3025798257
Source Documents
510(k) summary PDF not indicated by FDA