FDA Product Code
FDA Product Code SAF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1355
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261359 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2026-05-21 | Special | PDF ↗ |
| K250106 | Signos Glucose Monitoring System | Signos, Inc. | 2025-03-21 | Traditional | PDF ↗ |
| K233655 | Lingo Glucose System | Abbott | 2024-05-29 | Traditional | PDF ↗ |
| K234070 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2024-03-05 | Traditional | PDF ↗ |
Product code SAF · Class II · Clinical Chemistry. Data: openFDA.