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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 PHARMADX 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
Supplement NumberS004
Date Received12/23/2011
Decision Date06/01/2012
Product Code
NXG
Advisory Committee Pathology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the manufacturing process of pma oligomers in the device.
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