FDA 510(k) Application Details - K080909

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	K080909
Device Name	System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Applicant	IKONISYS INC 5 SCIENCE PARK SUITE 1000 NEW HAVEN, CT 06511 US Other 510(k) Applications for this Company
Contact	SYED ATAULLAH 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	04/01/2008
Decision Date	10/17/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review