FDA 510(k) Application Details - K111534

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K111534
Device Name	Counter, Differential Cell
Applicant	DIATRON US INC 14026 W. 107TH STREET LENEXA, KS 66215-2005 US Other 510(k) Applications for this Company
Contact	MICHAEL SWITZER 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	06/02/2011
Decision Date	08/02/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review