FDA 510(k) Application Details - K183100

Device Classification Name	Immunohistochemistry Antibody Assay, Estrogen Receptor   More FDA Info for this Device
510(K) Number	K183100
Device Name	Immunohistochemistry Antibody Assay, Estrogen Receptor
Applicant	Leica Biosystems Newcastle Limited Balliol Business Park West, Benton Lane Newcastle Upon Tyne NE12 8EW GB Other 510(k) Applications for this Company
Contact	Jeremy Allen 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	11/07/2018
Decision Date	12/07/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review