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Abbott Diabetes Care, Inc.

FDA 510(k) & PMA Approved Devices — 35 products

Total Devices35
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K233537 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemQBJ2024-04-23 View
510(k) K223435 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemQBJ2023-04-13 View
510(k) K222447 FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring SystemQBJ2023-03-03 View
510(k) K223537 FreeStyle Libre 2 System, FreeStyle Libre 3 SystemQLG2023-02-21 View
510(k) K212132 FreeStyle Libre 3 Continuous Glucose Monitoring SystemQLG2022-05-26 View
510(k) K213996 FreeStyle Libre 3 Continuous Glucose Monitoring SystemQLG2022-05-26 View
510(k) K210943 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)QLG2021-11-22 View
510(k) K211102 FreeStyle Libre 2 Flash Glucose Monitoring SystemQLG2021-08-11 View
510(k) K201761 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)QLG2021-07-30 View
510(k) K193371 FreeStyle Libre 2 Flash Glucose Monitoring SystemQLG2020-06-12 View
510(k) K171941 FreeStyle Precision Neo Blood Glucose Test StripsNBW2017-09-27 View
510(k) K153330 FreeStyle Precision Neo H Blood Glucose Monitoring SystemNBW2016-02-19 View
510(k) K132511 FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEMNBW2013-12-24 View
510(k) K120568 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMNBW2012-03-29 View
510(k) K092638 FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23NBW2010-06-15 View
510(k) K092602 FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring SystemNBW2010-05-14 View
510(k) K083223 RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01LFR2009-04-16 View
510(k) K083225 FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEMLZG2009-02-20 View
510(k) K081975 RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)NBW2008-11-26 View
510(k) K080960 PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPSNBW2008-09-05 View
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