FDA 510(k) Application Details - K050589

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K050589
Device Name	Counter, Differential Cell
Applicant	SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY MUNDELEIN, IL 60060 US Other 510(k) Applications for this Company
Contact	NINA GAMPERLING 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	03/08/2005
Decision Date	05/04/2005
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