Panels › Clinical Chemistry › Product code QLG · Class 2
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Regulation 862.1355
0510(k)s in 12 months (9 all time)
4recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in QLG
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Diabetes Care, Inc. | 7 | 8 |
| Bigfoot Biomedical, Inc. | 2 | 1 |
| Cardinal Health Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 1, 2023 | K222280 | Bigfoot Unity® Diabetes Management System Bigfoot Biomedical, Inc. | QLG |
| Feb 21, 2023 | K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 System Abbott Diabetes Care, Inc. | QLG |
| May 26, 2022 | K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System Abbott Diabetes Care, Inc. | QLG |
| May 26, 2022 | K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System Abbott Diabetes Care, Inc. | QLG |
| Nov 22, 2021 | K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) Abbott Diabetes Care, Inc. | QLG |
| Aug 11, 2021 | K211102 | FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care, Inc. | QLG |
| Jul 30, 2021 | K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) Abbott Diabetes Care, Inc. | QLG |
| May 7, 2021 | K202145 | Bigfoot Unity Diabetes Management System Bigfoot Biomedical, Inc. | QLG |
| Jun 12, 2020 | K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care, Inc. | QLG |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.