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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
510(k) Number K222447
Device Name FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System
Applicant
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda,  CA  94502
Applicant Contact Catherine Yang
Correspondent
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda,  CA  94502
Correspondent Contact Catherine Yang
Regulation Number862.1355
Classification Product Code
QBJ  
Subsequent Product Code
NBW  
Date Received08/15/2022
Decision Date 03/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT05251116
Reviewed by Third Party No
Combination Product No
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