Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System— 510(k) DEN250049
UnknownAbbott Diabetes Care
FDA 510(k) clearance DEN250049 for Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, Unknown on 2026-08-25. Applicant: Abbott Diabetes Care. Device class: 2.
Summary
Abbott Diabetes Care filed the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System. Its product code is SJD, integrated continuous glucose ketone monitoring systems.
Class II, 21 CFR 862.1354. Clinical Chemistry is both the classification panel and the review panel. The record lists the submission type as Direct.
Abbott Diabetes Care filed from Alameda, California. The decision date came 330 calendar days after the received date (September 29, 2025 to August 25, 2026).
Clearance details
- Applicant
- Abbott Diabetes Care
- Product code
- Product code SJD
- Device class
- Class 2
- Regulation
- 21 CFR 862.1354
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Alameda, CA, US
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