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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.
 
DeviceEGFR pharmDx
Generic NameImmunohistochemistry assay, antibody, epidermal growth factor receptor
Regulation Number864.1860
ApplicantAgilent Technologies, Inc.
5301 Stevens Creek Blvd.
Santa Clara, CA 95051
PMA NumberP030044
Supplement NumberS003
Date Received04/17/2017
Decision Date05/16/2017
Withdrawal Date04/11/2024
Product Code NQF 
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  
Changes to the relocation/ expansion of facility.
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