FDA Product Code
FDA Product Code SFU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1359
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262599 | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | 2026-09-18 | Traditional | PDF ↗ |
| DEN240080 | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | 2025-09-23 | Direct | — |
Product code SFU · Class II · Clinical Chemistry. Data: openFDA.