FDA 510(k) Application Details - K171655

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K171655
Device Name	Counter, Differential Cell
Applicant	Roche Diagnostics Hematology, Inc. 69 Milk Street, Suite 120 Westborough, MA 01581 US Other 510(k) Applications for this Company
Contact	Dan Bracco 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	06/05/2017
Decision Date	03/02/2018
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