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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.
Classification Nametest, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
Generic Namefluorescence in situ hybridization(fish) reagents
PMA NumberP030052
Supplement NumberS005
Date Received03/18/2011
Decision Date04/08/2011
Product Code
NSD[ Registered Establishments with NSD ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the reference dna manufacturing and the small scale fermentation processes.