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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