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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, Not For Use With Automated Insulin Delivery Systems
510(k) Number K213996
Device Name FreeStyle Libre 3 Continuous Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
1360 S. Loop Rd.
Alameda,  CA  94502
Applicant Contact Rodney Huang
Correspondent
Abbott Diabetes Care, Inc.
1360 S. Loop Rd.
Alameda,  CA  94502
Correspondent Contact Rodney Huang
Regulation Number862.1355
Classification Product Code
QLG  
Date Received12/20/2021
Decision Date 05/26/2022
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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