FDA 510(k) Application Details - K033982

Device Classification Name	System, Test, Tumor Marker, Monitoring, Bladder   More FDA Info for this Device
510(K) Number	K033982
Device Name	System, Test, Tumor Marker, Monitoring, Bladder
Applicant	VYSIS 3100 WOODCREEK DRIVE DOWNERS GROVE, IL 60515-5400 US Other 510(k) Applications for this Company
Contact	KERRY J FLOM Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	MMW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2003
Decision Date	01/22/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review