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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTOP2A 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
Supplement NumberS003
Date Received10/06/2011
Decision Date11/10/2011
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 
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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