FDA 510(k) Application Details - K032524

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K032524
Device Name	Counter, Differential Cell
Applicant	BAYER HEALTHCARE, LLC 511 BENEDICT AVE. TARRYTOWN, NY 10591 US Other 510(k) Applications for this Company
Contact	KENNETH T EDDS 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	08/15/2003
Decision Date	09/08/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review