FDA 510(k) Application Details - K162414

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K162414
Device Name	Counter, Differential Cell
Applicant	BECKMAN COULTER, INC. 11800 SW 147TH AVE. MIAMI, FL 33196 US Other 510(k) Applications for this Company
Contact	NANCY NADLER Other 510(k) Applications for this Contact
Regulation Number	864.5220   More FDA Info for this Regulation Number
Classification Product Code	GKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2016
Decision Date	11/29/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review