FDA 510(k) Application Details - K053520

Device Classification Name	Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity   More FDA Info for this Device
510(K) Number	K053520
Device Name	Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Applicant	TRIPATH IMAGING, INC. 4025 STIRRUP CREEK DRIVE STE. 400 DURHAM, NC 27703 US Other 510(k) Applications for this Company
Contact	BRYAN J TUCKER 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	12/19/2005
Decision Date	04/11/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review