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Abbott Diabetes Care, Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories5
Latest Approval2024-04-23
TypeNumberDevice NameCodeDate
510(k) K233537 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System QBJ 2024-04-23 View
510(k) K223435 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System QBJ 2023-04-13 View
510(k) K222447 FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System QBJ 2023-03-03 View
510(k) K223537 FreeStyle Libre 2 System, FreeStyle Libre 3 System QLG 2023-02-21 View
510(k) K213996 FreeStyle Libre 3 Continuous Glucose Monitoring System QLG 2022-05-26 View
510(k) K212132 FreeStyle Libre 3 Continuous Glucose Monitoring System QLG 2022-05-26 View
510(k) K210943 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) QLG 2021-11-22 View
510(k) K211102 FreeStyle Libre 2 Flash Glucose Monitoring System QLG 2021-08-11 View
510(k) K201761 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) QLG 2021-07-30 View
510(k) K193371 FreeStyle Libre 2 Flash Glucose Monitoring System QLG 2020-06-12 View
PMA P160030 Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated PZE 2017-12-29 View
510(k) K171941 FreeStyle Precision Neo Blood Glucose Test Strips NBW 2017-09-27 View
PMA P150021 Sensor, glucose, invasive MDS 2016-09-23 View
510(k) K153330 FreeStyle Precision Neo H Blood Glucose Monitoring System NBW 2016-02-19 View
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