FDA 510(k) Application Details - K110215

Device Classification Name	Immunohistochemistry Antibody Assay, Estrogen Receptor   More FDA Info for this Device
510(K) Number	K110215
Device Name	Immunohistochemistry Antibody Assay, Estrogen Receptor
Applicant	VENTANA MEDICAL SYSTEMS, INC. 1910 EAST 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	864.1860   More FDA Info for this Regulation Number
Classification Product Code	MYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2010
Decision Date	12/17/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review