FDA 510(k) Application Details - K080910

Device Classification Name	Microscope, Automated, Image Analysis, Operator Intervention   More FDA Info for this Device
510(K) Number	K080910
Device Name	Microscope, Automated, Image Analysis, Operator Intervention
Applicant	BIOIMAGENE, INC. 1601 S. DE ANZA BLVD SUITE 212 CUPERTINO, CA 95014 US Other 510(k) Applications for this Company
Contact	INDU LAKSHMAN Other 510(k) Applications for this Contact
Regulation Number	864.1860   More FDA Info for this Regulation Number
Classification Product Code	NOT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2008
Decision Date	02/04/2009
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