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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
510(k) Number K201761
Device Name FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
Applicant
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda,  CA  94502
Applicant Contact Ono Bacani
Correspondent
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda,  CA  94502
Correspondent Contact Ono Bacani
Regulation Number862.1355
Classification Product Code
QLG  
Subsequent Product Code
NBW  
Date Received06/29/2020
Decision Date 07/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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