FDA 510(k) Application Details - K170005

Device Classification Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor   More FDA Info for this Device
510(K) Number	K170005
Device Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor
Applicant	DAKO DENMARK A/S PRODUKTIONSVEJ 42 GLOSTRUP DK Other 510(k) Applications for this Company
Contact	LASSE POST MOLLER 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	01/03/2017
Decision Date	12/21/2017
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