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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceDAKO TOP2A FISH PHARMDX KIT
Classification Namefluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
Generic Namefluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
Applicant
DAKO DENMARK A/S
42 produktionsvej
2600 glostrup DK-26-2600
PMA NumberP050045
Date Received11/30/2005
Decision Date01/11/2008
Product Code
NXG[ Registered Establishments with NXG ]
Docket Number 08M-0182
Notice Date 03/20/2008
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the top2a fish pharmdx kit. The device is indicated for: top2a fish pharmdx kit is designed to detect amplifications and deletions (copy number changes) of the top2a gene using fluorescence in situ hybridization (fish) technique on formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Deletions and amplifications of the top2a gene serve as a marker for poor prognosis in high-risk breast cancer patients. Results from the top2a fish pharmdx kit are intended for use as an adjunct to existing clinical and pathological information.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 
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