FDA 510(k) Application Details - K130515

Device Classification Name	Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity   More FDA Info for this Device
510(K) Number	K130515
Device Name	Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Applicant	VENTANA MEDICAL SYSTEMS, INC. 575 Shirlynn Court Los Altos, CA 94022 US Other 510(k) Applications for this Company
Contact	ERIKA AMMIRATI Other 510(k) Applications for this Contact
Regulation Number	864.1860   More FDA Info for this Regulation Number
Classification Product Code	NQN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2013
Decision Date	11/22/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review