510(k) K233537 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Apr 23, 2024 |
| Received | Nov 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233537
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2026 | Abbott Diabetes Care, Inc. FreeStyle Libre 3 Plus Sensor REF 78768-01
UDI-DI code: 00357599844011
The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. Open, Classified |
QLG | None listed |
| Jan 14, 2026 | Abbott Diabetes Care, Inc. FreeStyle Libre 3 Plus Sensor REF 78769-01
UDI-DI code: 00357599843014
The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. Open, Classified |
QLG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.