FDA 510(k) Application Details - K062615

Device Classification Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor   More FDA Info for this Device
510(K) Number	K062615
Device Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor
Applicant	VISION BIOSYSTEMS INC. 1833 PORTOLA ROAD VENTURA, CA 93003 US Other 510(k) Applications for this Company
Contact	RONALD F LAGERQUIST 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	09/05/2006
Decision Date	01/29/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review