FDA 510(k) Application Details - K050191

Device Classification Name	More FDA Info for this Device
510(K) Number	K050191
Device Name	MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
Applicant	BECTON DICKINSON & CO. 2350 Qume Drive San Jose, CA 95131 US Other 510(k) Applications for this Company
Contact	CARTER NAVARRO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PER Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2005
Decision Date	02/22/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review