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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 Namefluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
PMA NumberP050045
Supplement NumberS001
Date Received01/28/2008
Decision Date02/13/2008
Product Code
NXG[ Registered Establishments with NXG ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the cen 17 reference pna probes and adjustment of the concentration of the top2a gene targeted dna probes in vial 3 probe mix.