510(k) K262599
- Device
- Biolinq Shine Autonomous Time-in-Range Microsensor
- Applicant
- Biolinq Incorporated
- 510(k) number
- K262599
- Product code
- SFU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-18
- Date received
- 2026-07-27
- Regulation
- 862.1359
- Classification name
- Glucose Range Monitoring System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Aly Alvarez
- Address
- 10260 Sorrento Valley Rd. San Diego CA US 92121 92121
FDA Registration Numbers#
- 2024024
- 3025798257
Source Documents#
Other 510(k) Records For Product Code SFU#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN240080 | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | 2025-09-23 |