510(k) clearance

Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System

FDA 510(k) source

510(k) number

DEN250049

Applicant

Abbott Diabetes Care

Decision date

Aug 25, 2026

Date received

Sep 29, 2025

Decision

Unknown

Clearance type

Direct

Product code

SJD

Device type

Integrated Continuous Glucose Ketone Monitoring System

Device class

Class II

Regulation

21 CFR 862.1354

Advisory committee

Clinical Chemistry

Third party

N

Location

Alameda, CA, US