FDA 510(k) Application Details - K031363

Device Classification Name	Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity   More FDA Info for this Device
510(K) Number	K031363
Device Name	Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Applicant	CELL ANALYSIS, INC. 1801 MAPLE AVENUE SUTIE 2319 EVANSTON, IL 60202 US Other 510(k) Applications for this Company
Contact	JOEL HERM 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	04/30/2003
Decision Date	02/05/2004
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