FDA 510(k) Application Details - K250943

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K250943
Device Name	Counter, Differential Cell
Applicant	Sysmex America, Inc. 577 Aptakisic Road Lincolnshire, IL 60069 US Other 510(k) Applications for this Company
Contact	Yvonne Doswell Other 510(k) Applications for this Contact
Regulation Number	864.5220   More FDA Info for this Regulation Number
Classification Product Code	GKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2025
Decision Date	06/25/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review