FDA 510(k) Application Details - K193393

Device Classification Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor   More FDA Info for this Device
510(K) Number	K193393
Device Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor
Applicant	Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane Newcastle Upon Tyne NE12 8EW GB Other 510(k) Applications for this Company
Contact	Matthew West 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	12/06/2019
Decision Date	03/06/2020
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