Clearance Summary
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit received FDA 510(k) clearance under submission number K181915, sponsored by Ixensor Co, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2019-04-12.
- Submission: K181915
- Applicant / Sponsor: Ixensor Co, Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2019-04-12
Classification & Regulation
This clearance is catalogued under FDA product code LCP and 21 CFR 864.7470, within the Hematology review panel as a Class II device.