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FDA 510(k) Applications for Medical Device Product Code "QLG"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K193371
Abbott Diabetes Care Inc.
FreeStyle Libre 2 Flash Glucose Monitoring System
06/12/2020
K210943
Abbott Diabetes Care Inc.
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
11/22/2021
K201761
Abbott Diabetes Care Inc.
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
07/30/2021
K223537
Abbott Diabetes Care Inc.
FreeStyle Libre 2 System, FreeStyle Libre 3 System
02/21/2023
K212132
Abbott Diabetes Care Inc.
FreeStyle Libre 3 Continuous Glucose Monitoring System
05/26/2022
K213996
Abbott Diabetes Care Inc.
FreeStyle Libre 3 Continuous Glucose Monitoring System
05/26/2022
K211102
Abbott Diabetes Care, Inc.
FreeStyle Libre 2 Flash Glucose Monitoring System
08/11/2021
K202145
Bigfoot Biomedical, Inc.
Bigfoot Unity Diabetes Management System
05/07/2021
K222280
Bigfoot Biomedical, Inc.
Bigfoot Unity« Diabetes Management System
03/01/2023
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