510(k) K213996 ยท QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
FreeStyle Libre 3 Continuous Glucose Monitoring System
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, May 26, 2022 |
| Received | Dec 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213996
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2024 | Abbott Diabetes Care, Inc. FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System Completed |
QLG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.