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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 NumberS012
Date Received03/13/2017
Decision Date04/12/2017
Withdrawal Date 01/24/2018
Product Code NYQ 
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Changes to the in-process control fluorescent labeling process.
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