FDA 510(k) Application Details - K042884

Device Classification Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor   More FDA Info for this Device
510(K) Number	K042884
Device Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor
Applicant	DAKOCYTOMATION CALIFORNIA, INC. 6392 VIA REAL CARPINTERIA, CA 93013 US Other 510(k) Applications for this Company
Contact	TIFFANY D ALMEROTH 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	10/19/2004
Decision Date	02/15/2005
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