FDA 510(k) Application Details - K060462

Device Classification Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor   More FDA Info for this Device
510(K) Number	K060462
Device Name	Immunohistochemistry Assay,Antibody,Progesterone Receptor
Applicant	LAB VISION CORP. 47777 WARM SPRINGS BLVD. FREMONT, CA 94539 US Other 510(k) Applications for this Company
Contact	GRACE CHANG 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	02/22/2006
Decision Date	04/24/2006
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