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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.
 
DevicePD-L1 IHC 22C3 PHARMDX
Generic Nameimmunohistochemistry assay, antibody, programmed death-ligand 1
ApplicantAgilent Technologies, Inc.
5301 stevens creek blvd
santa clara, CA 95051
PMA NumberP150013
Supplement NumberS004
Date Received12/27/2016
Decision Date03/24/2017
Product Code PLS 
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an update to DakoLink software version 4.2.
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