510(k) clearances

Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System

Abbott Diabetes Care · Clinical Chemistry

DEN250049UnknownDirectSJD
Open FDA's page for this record
Third party flag
N
City
Alameda
Advisory committee description
Clinical Chemistry
Address 1
1360 S. Loop Rd.
Product code
SJD
Zip code
94502
Applicant
Abbott Diabetes Care
Decision date
2026-08-25
Decision code
DENG
Country code
US
Device name
Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
Advisory committee
CH
Contact
Katherine Doll Kanne
K number
DEN250049
State
CA
Date received
2025-09-29
Review advisory committee
CH
Postal code
94502
Decision description
Unknown
Clearance type
Direct
Harmonized identifiers (openFDA)
Device name
Integrated Continuous Glucose Ketone Monitoring System
Medical specialty description
Clinical Chemistry
Regulation number
862.1354
Device class
2
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.