K233537
- 510(k) number
- K233537
- Device name
- FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc. CA · US
- Product code
- QBJ — Integrated Continuous Glucose Monitoring System, Fac
- Decision date
- 2024-04-23
- Date received
- 2023-11-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K233537.pdf
Official FDA record: K233537
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.