FDA 510(k) Applications Submitted by Abbott Diabetes Care Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K120568 02/27/2012 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC.
K081975 07/11/2008 RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) ABBOTT DIABETES CARE INC.
K092602 08/25/2009 FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System ABBOTT DIABETES CARE INC.
K092638 08/27/2009 FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 ABBOTT DIABETES CARE INC.
K083223 11/03/2008 RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01 ABBOTT DIABETES CARE INC.
K153330 11/19/2015 FreeStyle Precision Neo H Blood Glucose Monitoring System Abbott Diabetes Care Inc.
K222447 08/15/2022 FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System Abbott Diabetes Care Inc.
K171941 06/28/2017 FreeStyle Precision Neo Blood Glucose Test Strips Abbott Diabetes Care Inc.
K070850 03/28/2007 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC.
K051839 07/07/2005 FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 ABBOTT DIABETES CARE INC.
K020866 03/18/2002 FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM ABBOTT DIABETES CARE INC.
K031260 04/21/2003 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 ABBOTT DIABETES CARE INC.
K000582 02/22/2000 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 ABBOTT DIABETES CARE INC.
K012014 06/12/2001 MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC.
K992684 08/10/1999 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC.
K994433 12/30/1999 CONNECT DATA MANAGEMENT SYSTEM ABBOTT DIABETES CARE INC.
K223435 11/14/2022 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care Inc.
K050500 02/28/2005 FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC.
K051802 07/05/2005 FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC.
K060768 03/22/2006 PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS ABBOTT DIABETES CARE INC.
K070984 04/06/2007 THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS ABBOTT DIABETES CARE INC.
K051041 04/25/2005 INSULIN PUMP ABBOTT DIABETES CARE INC.
K062770 09/15/2006 COPILOT HEALTH MANAGEMENT SYSTEM ABBOTT DIABETES CARE INC.
K140371 02/14/2014 FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) ABBOTT DIABETES CARE INC.
K212132 07/08/2021 FreeStyle Libre 3 Continuous Glucose Monitoring System Abbott Diabetes Care Inc.
K193371 12/05/2019 FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care Inc.
K210943 03/30/2021 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) Abbott Diabetes Care Inc.
K201761 06/29/2020 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) Abbott Diabetes Care Inc.
K213996 12/20/2021 FreeStyle Libre 3 Continuous Glucose Monitoring System Abbott Diabetes Care Inc.
K071788 07/02/2007 AVIATOR INSULIN PUMP ABBOTT DIABETES CARE INC.
K083225 11/03/2008 FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC.
K223537 11/23/2022 FreeStyle Libre 2 System, FreeStyle Libre 3 System Abbott Diabetes Care Inc.
K080960 04/03/2008 PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS ABBOTT DIABETES CARE INC.
K132511 08/12/2013 FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM ABBOTT DIABETES CARE INC.


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