FDA 510(k) Application Details - K051693

Device Classification Name	Counter, Cell, Automated (Particle Counter)   More FDA Info for this Device
510(K) Number	K051693
Device Name	Counter, Cell, Automated (Particle Counter)
Applicant	BAYER HEALTHCARE, LLC 511 BENEDICT AVE. TARRYTOWN, NY 10591 US Other 510(k) Applications for this Company
Contact	ANDREA HOLLE 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	06/23/2005
Decision Date	12/07/2005
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