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U.S. Department of Health and Human Services

Devices@FDA
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Device Classification Name Integrated Continuous Glucose Monitoring System, Factory Calibrated
510(k) Number K223435
Device Name FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
1360 S. Loop Rd.
Alameda,  CA  94502
Applicant Contact Katherine L. Doll Kanne
Correspondent
Abbott Diabetes Care, Inc.
1360 S. Loop Rd.
Alameda,  CA  94502
Correspondent Contact Katherine L. Doll Kanne
Regulation Number862.1355
Classification Product Code
QBJ  
Subsequent Product Code
NBW  
Date Received11/14/2022
Decision Date 04/13/2023
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
Predetermined Change
Control Plan Authorized		 No
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