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 28-8 PHARMDX (Melanoma Indication) |
Generic Name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
Applicant | DAKO NORTH AMERICA, INC. 6392 VIA REAL CARPINTERIA, CA 93013 |
PMA Number | P150027 |
Supplement Number | S002 |
Date Received | 08/19/2016 |
Decision Date | 12/01/2016 |
APCB Date
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03/13/2017 |
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 the DakoLink software version 4.1 update for the PD-L1 IHC 28-8 pharmDx (melanoma indication). |
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