FDA 510(k) Application Details - K160922

Device Classification Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor   More FDA Info for this Device
510(K) Number	K160922
Device Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor
Applicant	Dako North America, Inc. 6392 Via Real Carpinteria, CA 93013 US Other 510(k) Applications for this Company
Contact	Joel Weisenberger 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	04/04/2016
Decision Date	05/03/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review