FDA 510(k) Application Details - K092333

Device Classification Name	Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity   More FDA Info for this Device
510(K) Number	K092333
Device Name	Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Applicant	BIOIMAGENE, INC. 919 HERMOSA CT. SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	INDU P LAKSHMAN Other 510(k) Applications for this Contact
Regulation Number	864.1860   More FDA Info for this Regulation Number
Classification Product Code	NQN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2009
Decision Date	10/27/2010
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