Abbott Diabetes Care, Inc.
FDA 510(k) & PMA Approved Devices — 14 products
Total Devices14
Categories5
Latest FDA decision2025-07-11
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P150021 | Sensor, glucose, invasive | MDS | 2025-07-11 | View |
| PMA | P160030 | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | PZE | 2025-07-11 | View |
| 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 |
| 510(k) | K171941 | FreeStyle Precision Neo Blood Glucose Test Strips | NBW | 2017-09-27 | View |
| 510(k) | K153330 | FreeStyle Precision Neo H Blood Glucose Monitoring System | NBW | 2016-02-19 | View |
No matching devices.