FDA 510(k) Application Details - K081286

Device Classification Name	Immunohistochemistry Antibody Assay, Estrogen Receptor   More FDA Info for this Device
510(K) Number	K081286
Device Name	Immunohistochemistry Antibody Assay, Estrogen Receptor
Applicant	DAKO NORTH AMERICA, INC. 6392 VIA REAL CARPINTERIA, CA 93013 US Other 510(k) Applications for this Company
Contact	KELLY MILLER 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	05/07/2008
Decision Date	05/08/2009
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