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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 K193371
Device Name FreeStyle Libre 2 Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda,  CA  94502
Applicant Contact Naveen Thuramalla
Correspondent
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda,  CA  94502
Correspondent Contact Naveen Thuramalla
Regulation Number862.1355
Classification Product Code
QLG  
Subsequent Product Code
NBW  
Date Received12/05/2019
Decision Date 06/12/2020
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
Recalls CDRH Recalls
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