FDA 510(k) Application Details - K000611

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K000611
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	JO-ANN E FABILA 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	02/23/2000
Decision Date	05/18/2000
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