PMA P150027S001
- Device
- PD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION)
- Applicant
- Dako North America, Inc.
- PMA number
- P150027
- Supplement
- S001
- Product code
- PLS
- Decision date
- 2016-10-05
- Classification
- Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- 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.
Current openFDA PMA Record#
- Device
- PD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION)
- Applicant
- Dako North America, Inc.
- PMA number
- P150027
- Supplement
- S001
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2016-10-05
- Decision code
- APPR
- Date received
- 2016-07-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.