Abbott Diabetes Care, Inc. - FDA 510(k) Cleared Devices
Recent clearances: FreeStyle Libre 3 Continuous Glucose Monitoring System, FreeStyle Libre 3 Continuous Glucose Monitoring System, FreeStyle Libre 2 Flash Glucose Monitoring System
37
Total
37
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abbott Diabetes Care, Inc. Chemistry ✕
34 devices
Cleared
Apr 23, 2024
FreeStyle Libre 3 Continuous Glucose Monitoring System
Chemistry
172d
Cleared
Apr 13, 2023
FreeStyle Libre 3 Continuous Glucose Monitoring System
Chemistry
150d
Cleared
CT
Mar 03, 2023
FreeStyle Libre 2 Flash Glucose Monitoring System
Chemistry
200d
Cleared
Feb 21, 2023
FreeStyle Libre 2 System, FreeStyle Libre 3 System
Chemistry
90d
Cleared
May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
Chemistry
322d
Cleared
May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
Chemistry
157d
Cleared
Nov 22, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
Chemistry
237d
Cleared
Aug 11, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System
Chemistry
120d
Cleared
Jul 30, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
Chemistry
396d
Cleared
Jun 12, 2020
FreeStyle Libre 2 Flash Glucose Monitoring System
Chemistry
190d
Cleared
Sep 27, 2017
FreeStyle Precision Neo Blood Glucose Test Strips
Chemistry
91d
Cleared
Feb 19, 2016
FreeStyle Precision Neo H Blood Glucose Monitoring System
Chemistry
92d