FDA 510(k) Application Details - DEN160019

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160019
Device Name	CINtec Histology (50 tests), CINtec Histology (250 tests)
Applicant	VENTANA MEDICAL SYSTEMS, INC 1910 E INNOVATION PARK DR TUCSON, AZ 85755 US Other 510(k) Applications for this Company
Contact	ROXANE BONNER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2016
Decision Date	03/04/2017
Decision	DENG -
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review