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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 K011031
Device Name VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
Applicant
VYSIS
3100 WOODCREEK DR.
DOWNERS GROVE,  IL  60515
Applicant Contact RUSSEL K ENNS
Correspondent
VYSIS
3100 WOODCREEK DR.
DOWNERS GROVE,  IL  60515
Correspondent Contact RUSSEL K ENNS
Regulation Number866.6010
Classification Product Code
MMW  
Date Received04/05/2001
Decision Date 08/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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