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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 NumberS003
Date Received09/20/2012
Decision Date11/27/2012
Withdrawal Date 01/24/2018
Product Code NYQ 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE MOUNTING MEDIUM REAGENT SUPPLIED IN THE KIT.
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