Clearance Summary
FreeStyle Libre 2 Flash Glucose Monitoring System received FDA 510(k) clearance under submission number K193371, sponsored by Abbott Diabetes Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2020-06-12.
- Submission: K193371
- Applicant / Sponsor: Abbott Diabetes Care, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1355
- Decision date: 2020-06-12
Classification & Regulation
This clearance is catalogued under FDA product code QLG and 21 CFR 862.1355, within the Clinical Chemistry review panel as a Class II device.