Clearance Summary
PixoTest Blood Glucose Monitoring System received FDA 510(k) clearance under submission number K163087, sponsored by Ixensor Company , Ltd.. 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 2017-11-02.
- Submission: K163087
- Applicant / Sponsor: Ixensor Company , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2017-11-02
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.