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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.
 
DeviceTOP2A FISH PHARMDX
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
Supplement NumberS002
Date Received03/06/2008
Decision Date03/26/2008
Product Code
NXG[ Registered Establishments with NXG ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in auxiliary material/supplier used in the production of the probe mix to eliminate enzyme related stability problems.
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