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. |
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Device | PD-L1 IHC 22C3 PHARMDX |
Generic Name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
Applicant | Agilent Technologies, Inc. 5301 Stevens Creek Blvd Santa Clara, CA 95051 |
PMA Number | P150013 |
Supplement Number | S002 |
Date Received | 06/28/2016 |
Decision Date | 09/23/2016 |
Product Code |
PLS |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for addition of the Dako PT Link PT200 programmable water bath for pre-treatment of tissue sections when using PD-L1 IHC 22C3 pharmDx. |
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