FDA 510(k) Application Details - K141932

Device Classification Name	More FDA Info for this Device
510(K) Number	K141932
Device Name	AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
Applicant	BECKMAN COULTER, INC. 11800 SW 147TH AVE MIAMI, FL 33196 US Other 510(k) Applications for this Company
Contact	ANTHONY DENNIS 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	07/16/2014
Decision Date	04/10/2015
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