Clearance Summary
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER received FDA 510(k) clearance under submission number K053135, sponsored by Sysmex America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2006-01-04.
- Submission: K053135
- Applicant / Sponsor: Sysmex America, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5200
- Decision date: 2006-01-04
Classification & Regulation
This clearance is catalogued under FDA product code LKM and 21 CFR 864.5200, within the Hematology review panel as a Class II device.