FDA 510(k) Application Details - K162897

Device Classification Name	More FDA Info for this Device
510(K) Number	K162897
Device Name	Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser
Applicant	BECKMAN COULTER 11800 SW 147TH AVE MIAMI, FL 33196-2500 US Other 510(k) Applications for this Company
Contact	Suzana Otano Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2016
Decision Date	06/23/2017
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