FDA 510(k) Application Details - K031715

Device Classification Name	Microscope, Automated, Image Analysis, Operator Intervention   More FDA Info for this Device
510(K) Number	K031715
Device Name	Microscope, Automated, Image Analysis, Operator Intervention
Applicant	APPLIED IMAGING CORP. 2380 WALSH AVE., BLDG.B SANTA CLARA, CA 95051 US Other 510(k) Applications for this Company
Contact	DIANE C OATES 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	06/02/2003
Decision Date	01/08/2004
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