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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
Classification Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
Generic Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
Applicant
DAKO DENMARK A/S
42 produktionsvej
dk-2600
glostrup DK-26-2600
PMA NumberP100024
Supplement NumberS004
Date Received11/16/2012
Decision Date04/19/2013
Product Code
NYQ[ Registered Establishments with NYQ ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE DAKOLINK V4.0 SOFTWARE FOR HER2 CISH PHARMDX¿ KIT.
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