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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.
 
DeviceHER2 CISH PHARMDX KIT
Generic NameChromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
ApplicantDAKO DENMARK A/S
42 PRODUKTIONSVEJ
DK-2600
GLOSTRUP DK-26-2600
PMA NumberP100024
Supplement NumberS004
Date Received11/16/2012
Decision Date04/19/2013
Withdrawal Date 01/24/2018
Product Code NYQ 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE DAKOLINK V4.0 SOFTWARE FOR HER2 CISH PHARMDX¿ KIT.
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