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Abbott Diabetes Care, Inc.

37 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System (K233537)Abbott Diabetes Care, Inc.2024-04-23
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System (K223435)Abbott Diabetes Care, Inc.2023-04-13
FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System (K222447)Abbott Diabetes Care, Inc.2023-03-03
FreeStyle Libre 2 System, FreeStyle Libre 3 System (K223537)Abbott Diabetes Care, Inc.2023-02-21
FreeStyle Libre 3 Continuous Glucose Monitoring System (K212132)Abbott Diabetes Care, Inc.2022-05-26
FreeStyle Libre 3 Continuous Glucose Monitoring System (K213996)Abbott Diabetes Care, Inc.2022-05-26
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K210943)Abbott Diabetes Care, Inc.2021-11-22
FreeStyle Libre 2 Flash Glucose Monitoring System (K211102)Abbott Diabetes Care, Inc.2021-08-11
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K201761)Abbott Diabetes Care, Inc.2021-07-30
FreeStyle Libre 2 Flash Glucose Monitoring System (K193371)Abbott Diabetes Care, Inc.2020-06-12
FreeStyle Precision Neo Blood Glucose Test Strips (K171941)Abbott Diabetes Care, Inc.2017-09-27
FreeStyle Precision Neo H Blood Glucose Monitoring System (K153330)Abbott Diabetes Care, Inc.2016-02-19
FreeStyle Precision Neo Blood Glucose Monitoring System (K142928)Abbott Diabetes Care, Inc.2015-09-30
FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) (K140371)Abbott Diabetes Care, Inc.2014-09-30
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM (K132511)Abbott Diabetes Care, Inc.2013-12-24
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM (K120568)Abbott Diabetes Care, Inc.2012-03-29
FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 (K092638)Abbott Diabetes Care, Inc.2010-06-15
FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System (K092602)Abbott Diabetes Care, Inc.2010-05-14
RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01 (K083223)Abbott Diabetes Care, Inc.2009-04-16
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM (K083225)Abbott Diabetes Care, Inc.2009-02-20
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) (K081975)Abbott Diabetes Care, Inc.2008-11-26
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS (K080960)Abbott Diabetes Care, Inc.2008-09-05
AVIATOR INSULIN PUMP (K071788)Abbott Diabetes Care, Inc.2008-01-11
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS (K070984)Abbott Diabetes Care, Inc.2007-11-01
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM (K070850)Abbott Diabetes Care, Inc.2007-04-10
COPILOT HEALTH MANAGEMENT SYSTEM (K062770)Abbott Diabetes Care, Inc.2006-12-14
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS (K060768)Abbott Diabetes Care, Inc.2006-04-21
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 (K051839)Abbott Diabetes Care, Inc.2006-03-09
INSULIN PUMP (K051041)Abbott Diabetes Care, Inc.2005-12-23
FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM (K051802)Abbott Diabetes Care, Inc.2005-08-09
FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM (K050500)Abbott Diabetes Care, Inc.2005-06-27
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 (K031260)Abbott Diabetes Care, Inc.2003-12-19
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM (K020866)Abbott Diabetes Care, Inc.2002-06-11
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM (K012014)Abbott Diabetes Care, Inc.2001-12-05
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 (K000582)Abbott Diabetes Care, Inc.2000-12-05
CONNECT DATA MANAGEMENT SYSTEM (K994433)Abbott Diabetes Care, Inc.2000-05-05
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM (K992684)Abbott Diabetes Care, Inc.2000-01-14

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Every clearance here is in the API, with alerts when new ones post.