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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 NumberS002
Date Received01/17/2007
Decision Date02/06/2007
Product Code
NSD[ Registered Establishments with NSD ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the thermobrite automated slide heating plate supplied by an alternate vendor as an optional alternative of the hybrite automated slide heating plate instrument and to add instructions for use of said thermobrite to the current urovysion bladder cancer kit package insert.
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