FDA 510(k) Application Details - K071141

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K071141
Device Name	Counter, Differential Cell
Applicant	BD Biosciences 2350 QUME DR. SAN JOSE, CA 95131-1807 US Other 510(k) Applications for this Company
Contact	NOBUKO NAKAJIMA 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	04/24/2007
Decision Date	06/06/2007
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