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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
Classification Nameimmunohistochemistry antibody assay, c-kit
Generic Nameimmunohistochemistry antibody assay, c-kit
Regulation Number864.1860
Applicant
DAKO NORTH AMERICA, INC.
6392 via real
carpinteria, CA 93013
PMA NumberP040011
Supplement NumberS002
Date Received10/16/2012
Decision Date11/02/2012
Product Code
NKF[ Registered Establishments with 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 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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