FDA 510(k) Application Details - K012960

Device Classification Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor   More FDA Info for this Device
510(K) Number	K012960
Device Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor
Applicant	BIOGENEX LABORATORIES 4600 NORRIS CANYON RD. SAN RAMON, CA 94583 US Other 510(k) Applications for this Company
Contact	GURVINDER S NANDA 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	09/04/2001
Decision Date	03/08/2002
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