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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.
 
DeviceMMR IHC Panel pharmDx (Dako Omnis)
Generic NameImmunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Regulation Number864.1860
ApplicantAgilent Technologies, Inc.
6392 Via Real
Carpinteria, CA 93013
PMA NumberP250004
Supplement NumberS001
Date Received08/14/2026
Decision Date09/11/2026
Product Code QNH 
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 of manufacturing process and equipment changes for filling and capping
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