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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
Applicant
DAKO DENMARK A/S
42 produktionsvej
dk-2600
glostrup DK-26-2600
PMA NumberP100024
Supplement NumberS006
Date Received12/03/2014
Decision Date12/29/2014
Product Code NYQ 
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
MODIFICATION OF THE QUALITY CONTROL FOR INCOMING ALU-PNAS MATERIALS TOREDUCE HIGH BACKGROUND SIGNAL IN THE NEGATIVE CONTROLS.
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