FDA 510(k) Application Details - DEN040010

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	DEN040010
Device Name	System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Applicant	VYSIS 3100 WOODCREEK DR. DOWNERS GROVE, IL 60515 US Other 510(k) Applications for this Company
Contact	LYNDA HAGUE 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	10/13/2004
Decision Date	12/13/2004
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review