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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name integrated continuous glucose ketone monitoring system
De Novo Number DEN250049
Device Name Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
Requester
abbott diabetes care
1360 s. loop rd.
alameda,  CA  94502
Contact katherine doll kanne
Regulation Number862.1354
Classification Product Code
SJD  
Date Received09/29/2025
Decision Date 08/25/2026
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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