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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.
Generic Nameimmunohistochemistry assay, antibody, anaplastic lymphoma kinase
1910 east innovation park dr.
tucson, AZ 85755
PMA NumberP140025
Supplement NumberS003
Date Received03/22/2016
Decision Date10/21/2016
Product Code PKW 
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for adding the BenchMark ULTRA instrument to the intended use and labeling for the VENTANA ALK (D5F3) CDx Assay