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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 K233537
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  94202
Applicant Contact Sapna Ghelani
Correspondent
Abbott Diabetes Care, Inc.
1360 S. Loop Rd.
Alameda,  CA  94202
Correspondent Contact Sapna Ghelani
Regulation Number862.1355
Classification Product Code
QBJ  
Subsequent Product Codes
NBW   QLG  
Date Received11/03/2023
Decision Date 04/23/2024
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
Recalls CDRH Recalls
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