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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.
 
DeviceDAKO C-KIT PHARMDX
Generic NameImmunohistochemistry antibody assay, c-kit
Regulation Number864.1860
ApplicantDako North America, Inc.
6392 Via Real
Carpinteria, CA 93013
PMA NumberP040011
Supplement NumberS001
Date Received03/29/2007
Decision Date04/23/2007
Withdrawal Date05/23/2018
Product Code NKF 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO PERFORM TARGET RETRIEVAL AT AN INCREASED TEMPERATURE AND SHORTER INCUBATION TIME UNDER PRESSURE.
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