FDA 510(k) Applications for Medical Device Product Code "QBJ"

FDA 510(k) Number Applicant Device Name Decision Date
K222447 Abbott Diabetes Care Inc. FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System 03/03/2023
K223435 Abbott Diabetes Care Inc. FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System 04/13/2023
K201328 Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring (CGM) System 07/15/2021
K223931 Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring (CGM) System 01/11/2023
K221259 Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System 07/29/2022
K183206 Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring System 02/14/2019
DEN170088 Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring System 03/27/2018
K200876 Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System 12/04/2020
K191450 Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System 06/28/2019
K231081 Dexcom, Inc. Dexcom G7 Continuous Glucose Monitoring (CGM) System 05/15/2023
K213919 Dexcom, Inc. Dexcom G7 Continuous Glucose Monitoring System 12/07/2022


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact