FDA 510(k) Application Details - K981761

Device Classification Name	Counter, Cell, Automated (Particle Counter)   More FDA Info for this Device
510(K) Number	K981761
Device Name	Counter, Cell, Automated (Particle Counter)
Applicant	SYSMEX CORP. ONE WILDLIFE WAY LONG GROVE, IL 60047-9596 US Other 510(k) Applications for this Company
Contact	NINA GAMPERLING Other 510(k) Applications for this Contact
Regulation Number	864.5200   More FDA Info for this Regulation Number
Classification Product Code	GKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/1998
Decision Date	08/14/1998
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