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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceURO VYSION BLADDER CANCER KIT ASSAY
Generic NameTest, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
ApplicantABBOTT MOLECULAR
1300 E. Touhy Avenue
Des Plaines, IL 60018
PMA NumberP030052
Supplement NumberS008
Date Received06/23/2011
Decision Date07/20/2011
Product Code NSD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
IMPLEMENTATION OF AN IN-PROCESS VALIDATED TEST METHOD FOR RESTRICTION ENZYME DIGEST GEL ELECTROPHORESIS (DNA RESTRICTION ANALYSIS), CHANGE IN DIGEST RESTRICTION ENZYMES USED IN THE IN-PROCESS TEST, IMPLEMENTATION OF AN IN-PROCESS VALIDATED TEST METHOD FOR DNA CONCENTRATION DETERMINATION BY UV/VIS ABSORBANCE SPECTROPHOTOMETRY, AND ADDITION OF AN INCOMING SCREENING TEST FOR DEXTRAN SULFATE.
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