FDA Product Code
FDA Product Code SBH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1355
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262472 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2026-08-11 | Special | PDF ↗ |
| K260935 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2026-06-12 | Traditional | PDF ↗ |
| K233861 | Libre Rio Continuous Glucose Monitoring System | Abbott Diabetes Care | 2024-06-07 | Traditional | PDF ↗ |
Product code SBH · Class II · Clinical Chemistry. Data: openFDA.