DEN250049
- 510(k) number
- DEN250049
- Device name
- Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
- Applicant
- Abbott Diabetes Care CA · US
- Product code
- SJD not yet in the FDA classification database
- Decision date
- 2026-08-25
- Date received
- 2025-09-29
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Unknown
Official FDA record: DEN250049
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.