510(k) K210943 ยท QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Nov 22, 2021 |
| Received | Mar 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210943
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.