FDA 510(k) Application Details - K131301

Device Classification Name	More FDA Info for this Device
510(K) Number	K131301
Device Name	BD FACS SAMPLE PREP ASSISTANT III
Applicant	BECTON DICKINSON & CO. 2350 Qume Drive San Jose, CA 95131 US Other 510(k) Applications for this Company
Contact	KIMBERLY LIEDTKE 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	05/07/2013
Decision Date	08/02/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review