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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.
 
DeviceC-KIT PHARMDX
Generic NameImmunohistochemistry antibody assay, c-kit
Regulation Number864.1860
ApplicantDAKO NORTH AMERICA, INC.
6392 VIA REAL
CARPINTERIA, CA 93013
PMA NumberP040011
Supplement NumberS002
Date Received10/16/2012
Decision Date11/02/2012
Withdrawal Date 05/23/2018
Product Code NKF 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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