FDA 510(k) Application Details - K011031

Device Classification Name	System, Test, Tumor Marker, Monitoring, Bladder   More FDA Info for this Device
510(K) Number	K011031
Device Name	System, Test, Tumor Marker, Monitoring, Bladder
Applicant	VYSIS 3100 WOODCREEK DR. DOWNERS GROVE, IL 60515 US Other 510(k) Applications for this Company
Contact	RUSSEL K ENNS 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	04/05/2001
Decision Date	08/03/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review