FDA Product Code
FDA Product Code QLG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1355
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K222280 | Bigfoot Unity® Diabetes Management System | Bigfoot Biomedical, Inc. | 2023-03-01 | Traditional | PDF ↗ |
| K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 System | Abbott Diabetes Care, Inc. | 2023-02-21 | Traditional | PDF ↗ |
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2022-05-26 | Traditional | PDF ↗ |
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2022-05-26 | Traditional | PDF ↗ |
| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Abbott Diabetes Care, Inc. | 2021-11-22 | Traditional | PDF ↗ |
| K211102 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2021-08-11 | Traditional | PDF ↗ |
| K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Abbott Diabetes Care, Inc. | 2021-07-30 | Traditional | PDF ↗ |
| K202145 | Bigfoot Unity Diabetes Management System | Bigfoot Biomedical, Inc. | 2021-05-07 | Traditional | PDF ↗ |
| K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2020-06-12 | Traditional | PDF ↗ |
Product code QLG · Class II · Clinical Chemistry. Data: openFDA.