FDA 510(k) Application Details - K122556

Device Classification Name	Immunohistochemistry Antibody Assay, Estrogen Receptor   More FDA Info for this Device
510(K) Number	K122556
Device Name	Immunohistochemistry Antibody Assay, Estrogen Receptor
Applicant	LEICA BIOSYSTEMS NEWCASTLE LTD 5205 Route 12 Richmond, IL 60071 US Other 510(k) Applications for this Company
Contact	BARBARA-ANN CONWAY-MAYERS 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	08/22/2012
Decision Date	05/19/2014
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