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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameC-KIT PHARMDX
Classification Nameimmunohistochemistry antibody assay, c-kit
Generic Namedakocytomation rabbit anti-human c-kit immunohistochemistry kit
Regulation Number864.1860
ApplicantDAKO NORTH AMERICA, INC.
PMA NumberP040011
Supplement NumberS002
Date Received10/16/2012
Decision Date11/02/2012
Product Code
NKF[ Registered Establishments with NKF ]
Advisory Committee Immunology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the company prefix to the device name (from dakocytomation c-kit pharmdx to c-kit pharmdx). The device, as modified, will be marketed under the trade name c-kit pharmdx.
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