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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, tumor marker, monitoring, bladder
510(k) Number K033982
Device Name MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
Original Applicant
VYSIS
3100 woodcreek drive
downers grove,  IL  60515 5400
Original Contact kerry j flom
Regulation Number866.6010
Classification Product Code
MMW  
Date Received12/23/2003
Decision Date 01/22/2004
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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