Clearance Summary
Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System received FDA 510(k) clearance under submission number DEN250049, sponsored by Abbott Diabetes Care. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2026-08-25.
- Submission: DEN250049
- Applicant / Sponsor: Abbott Diabetes Care
- Clearance pathway: Direct
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1354
- Decision date: 2026-08-25
Classification & Regulation
This clearance is catalogued under FDA product code SJD and 21 CFR 862.1354, within the Clinical Chemistry review panel as a Class II device.