Libre Rio Continuous Glucose Monitoring System
FDA 510(k) clearance K233861 · decided 2024-06-07
Clearance details
- K-number
- K233861
- Device name
- Libre Rio Continuous Glucose Monitoring System
- Applicant
- Abbott Diabetes Care
- Decision
- Substantially Equivalent
- Date received
- 2023-12-06
- Decision date
- 2024-06-07
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- SBH
- Device class
- 2
- Regulation number
- 862.1355
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Alameda, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Stelo Glucose Biosensor System (K260935) | Dexcom, Inc. | 2026-06-12 |
Recalls involving this device
No recalls on record reference this clearance.