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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 NumberS001
Date Received01/28/2008
Decision Date02/13/2008
Withdrawal Date 01/24/2018
Product Code NXG 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATION OF THE CEN 17 REFERENCE PNA PROBES AND ADJUSTMENT OF THE CONCENTRATION OF THE TOP2A GENE TARGETED DNA PROBES IN VIAL 3 PROBE MIX.
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