FDA 510(k) Application Details - K061360

Device Classification Name	Immunohistochemistry Antibody Assay, Estrogen Receptor   More FDA Info for this Device
510(K) Number	K061360
Device Name	Immunohistochemistry Antibody Assay, Estrogen Receptor
Applicant	LAB VISION CORP. 47777 WARM SPRINGS BLVD. FREMONT, CA 94539 US Other 510(k) Applications for this Company
Contact	GRACE HSIAO-FEN CHANG Other 510(k) Applications for this Contact
Regulation Number	864.1860   More FDA Info for this Regulation Number
Classification Product Code	MYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2006
Decision Date	06/27/2006
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