FDA 510(k) Application Details - K964375

Device Classification Name	Counter, Cell, Automated (Particle Counter)   More FDA Info for this Device
510(K) Number	K964375
Device Name	Counter, Cell, Automated (Particle Counter)
Applicant	SYSMEX CORP. GILMER RD. 6699 RFD LONG GROVE, IL 60047-9596 US Other 510(k) Applications for this Company
Contact	CATHERINE M TRESTER, MT(ASCP) 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	11/01/1996
Decision Date	03/13/1997
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