FDA 510(k) Application Details - K043519

Device Classification Name	System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays   More FDA Info for this Device
510(K) Number	K043519
Device Name	System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Applicant	APPLIED IMAGING CORP. 120 BAYTECH DRIVE SAN JOSE, CA 95134-2302 US Other 510(k) Applications for this Company
Contact	DIANE C DAY Other 510(k) Applications for this Contact
Regulation Number	866.4700   More FDA Info for this Regulation Number
Classification Product Code	NTH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2004
Decision Date	04/25/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review