|
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 | S001 |
Date Received | 07/07/2016 |
Decision Date | 10/05/2016 |
APCB Date
|
03/13/2017 |
Product Code |
PLS |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for addition of the PT Link PT200 for pre-treatment of tissue sections prior to staining with PD-L1 IHC 28-8 pharmDx. |