Medical Device Manufacturer · US , Alameda , CA

Abbott Diabetes Care, Inc.

37 submissions · 37 cleared · Since 2000
37
Total
37
Cleared
0
Denied

Abbott Diabetes Care, Inc. — FDA 510(k) Submissions

Abbott Diabetes Care, Inc. has submitted 37 FDA 510(k) premarket notifications since 2000, of which 37 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Blood Glucose, Over The Counter, Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems, Glucose Dehydrogenase, Glucose, Integrated Continuous Glucose Monitoring System, Factory Calibrated, Pump, Infusion, Insulin . Use the specialty filter in the sidebar to narrow results.

37 devices
1–25 of 37
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
K233537 · QBJ Integrated Continuous... · Chemistry
Apr 2024 172d
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
K223435 · QBJ Integrated Continuous... · Chemistry
Apr 2023 150d
FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System
K222447 · QBJ Integrated Continuous... · Chemistry
Mar 2023 200d
FreeStyle Libre 2 System, FreeStyle Libre 3 System
K223537 · QLG Integrated Continuous... · Chemistry
Feb 2023 90d
FreeStyle Libre 3 Continuous Glucose Monitoring System
K212132 · QLG Integrated Continuous... · Chemistry
May 2022 322d
FreeStyle Libre 3 Continuous Glucose Monitoring System
K213996 · QLG Integrated Continuous... · Chemistry
May 2022 157d
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K210943 · QLG Integrated Continuous... · Chemistry
Nov 2021 237d
FreeStyle Libre 2 Flash Glucose Monitoring System
K211102 · QLG Integrated Continuous... · Chemistry
Aug 2021 120d
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K201761 · QLG Integrated Continuous... · Chemistry
Jul 2021 396d
FreeStyle Libre 2 Flash Glucose Monitoring System
K193371 · QLG Integrated Continuous... · Chemistry
Jun 2020 190d
FreeStyle Precision Neo Blood Glucose Test Strips
K171941 · NBW System, Test, Blood... · Chemistry
Sep 2017 91d
FreeStyle Precision Neo H Blood Glucose Monitoring System
K153330 · NBW System, Test, Blood... · Chemistry
Feb 2016 92d
FreeStyle Precision Neo Blood Glucose Monitoring System
K142928 · NBW System, Test, Blood... · Chemistry
Sep 2015 356d
FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)
K140371 · NBW System, Test, Blood... · Chemistry
Sep 2014 228d
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K132511 · NBW System, Test, Blood... · Chemistry
Dec 2013 134d
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
K120568 · NBW System, Test, Blood... · Chemistry
Mar 2012 31d
FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23
K092638 · NBW System, Test, Blood... · Chemistry
Jun 2010 292d
FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System
K092602 · NBW System, Test, Blood... · Chemistry
May 2010 262d
RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
K083223 · LFR Glucose Dehydrogenase,... · Chemistry
Apr 2009 164d
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
K083225 · LZG Pump, Infusion, Insulin · General Hospital
Feb 2009 109d
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)
K081975 · NBW System, Test, Blood... · Chemistry
Nov 2008 138d
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS
K080960 · NBW System, Test, Blood... · Chemistry
Sep 2008 155d
AVIATOR INSULIN PUMP
K071788 · LZG Pump, Infusion, Insulin · General Hospital
Jan 2008 193d
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
K070984 · LFR Glucose Dehydrogenase,... · Chemistry
Nov 2007 209d
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
K070850 · NBW System, Test, Blood... · Chemistry
Apr 2007 13d
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