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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 NameTOP2A FISH PHARMDX KIT
Classification Namefluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
ApplicantDAKO DENMARK A/S
PMA NumberP050045
Supplement NumberS003
Date Received10/11/2011
Decision Date11/10/2011
Product Code
NXG[ Registered Establishments with NXG ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Add an alternate supplier of texas red labeled dctp nucleotide and to replace an in-process qc procedure with a new qc test on ffpe breast cancer tissue.
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