Clearance Summary
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance under submission number K014167, sponsored by Polymedica Pharmaceuticals, U.S.A., 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 2002-02-19.
- Submission: K014167
- Applicant / Sponsor: Polymedica Pharmaceuticals, U.S.A., Inc.]
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2002-02-19
Classification & Regulation
This clearance is catalogued under FDA product code NBW and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.