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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.
 
DeviceKi-67 IHC MIB-1 pharmDx (Dako Omnis)
Generic NameImmunohistochemistry assay, antibody, Ki-67
ApplicantAgilent Technologies, Inc.
5301 Stevens Creek Blvd.
Santa Clara, CA 95051
PMA NumberP210026
Supplement NumberS002
Date Received01/31/2025
Decision Date02/28/2025
Product Code QQT 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for additional quality control tests to raw materials and intermediates that to enhance safety of the finished devices without impacting effectiveness.
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