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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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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
Classification Product Code
SJD
Date Received09/29/2025
Decision Date 08/25/2026
Decision granted (DENG)
Review Advisory Committee Clinical Chemistry
Type Direct
Predetermined Change
Control Plan Authorized		 No
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