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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameUROVYSION BLADDER CANCER KIT
Classification Nametest, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
Generic Namefluorescence in situ hybridization(fish) reagents
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP030052
Supplement NumberS012
Date Received08/29/2013
Decision Date01/24/2014
Product Code
NSD[ Registered Establishments with NSD ]
Advisory Committee Immunology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at leica biosystems in solon mills, illinois.
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