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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.
 
DeviceHercepTest™
Generic NameSYSTEM, TEST, HER-2/NEU, IHC
ApplicantAgilent Technologies Singapore (International) Pte , Ltd.
# 1 Yishun Ave. 7
Singapore 768923
PMA NumberP980018
Supplement NumberS027
Date Received07/20/2026
Decision Date09/21/2026
Product Code MVC 
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  
approval for a supplier's change to the manufacturing sight for a device component
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