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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 NumberS008
Date Received01/08/2016
Decision Date01/29/2016
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 ProductNo
Approval Order Statement  
CHANGE OF THE IN-PROCESS QC "METAPHASE FISH TEST', WITH CHANGE NUMBER R02285. PMA APPROVED DEVICES AFFECTED BY THE CHANGE ARE: HER2 CISH PHARMDX KIT AND HER2 IQFISH PHARMDX.
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