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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.
 
DeviceVENTANA ALK (D5F3) CDx Assay
Generic NameImmunohistochemistry assay, antibody, anaplastic lymphoma kinase
ApplicantVentana Medical Systems, Inc.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP140025
Supplement NumberS024
Date Received12/08/2023
Decision Date03/12/2025
Product Code PKW 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the migration of the VENTANA ALK (D5F3) Assay from BenchMark ULTRA to BenchMark ULTRA PLUS instrument
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