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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
Generic NameFluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
ApplicantDAKO DENMARK A/S
42 PRODUKTIONSVEJ
2600 GLOSTRUP DK-26-2600
PMA NumberP050045
Supplement NumberS003
Date Received10/06/2011
Decision Date11/10/2011
Withdrawal Date 01/24/2018
Product Code NXG 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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