FDA 510(k) Application Details - K103818

Device Classification Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor   More FDA Info for this Device
510(K) Number	K103818
Device Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor
Applicant	VENTANA MEDICAL SYTEMS, INC 1910 E. INNOVATIONS PARK DRIVE TUCSON, AZ 85755 US Other 510(k) Applications for this Company
Contact	GEORGE DE LA ROSA Other 510(k) Applications for this Contact
Regulation Number	864.1860   More FDA Info for this Regulation Number
Classification Product Code	MXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2010
Decision Date	11/16/2011
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