Clearance Summary
Sysmex XW-100 Automated Hematology Analyzer received FDA 510(k) clearance under submission number K210346, sponsored by Sysmex America, Inc.. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2022-11-08.
- Submission: K210346
- Applicant / Sponsor: Sysmex America, Inc.
- Clearance pathway: Dual Track
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 2022-11-08
Classification & Regulation
This clearance is catalogued under FDA product code GKZ and 21 CFR 864.5220, within the Hematology review panel as a Class II device.