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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 NameDAKO C-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 NumberS001
Date Received03/29/2007
Decision Date04/23/2007
Product Code
NKF[ Registered Establishments with NKF ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to perform target retrieval at an increased temperature and shorter incubation time under pressure.
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