FDA 510(k) Application Details - K150815

Device Classification Name	More FDA Info for this Device
510(K) Number	K150815
Device Name	BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit
Applicant	Becton, Dickinson and Company 2350 Qume Dr. San Jose, CA 95131 US Other 510(k) Applications for this Company
Contact	Catherine(Katie) Bessette Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2015
Decision Date	12/17/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review