510(k) K193371 ยท QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
FreeStyle Libre 2 Flash Glucose Monitoring System
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Jun 12, 2020 |
| Received | Dec 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193371
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2023 | Abbott Diabetes Care, Inc. FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System Open, Classified |
QLG | None listed |
| Apr 6, 2023 | Abbott Diabetes Care, Inc. FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System Open, Classified |
QLG | None listed |
| Mar 16, 2021 | Cardinal Health Inc. FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877 Open, Classified |
QLG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.