PMA P150027S002
- Device
- PD-L1 IHC 28-8 PHARMDX (Melanoma Indication)
- Applicant
- Dako North America, Inc.
- PMA number
- P150027
- Supplement
- S002
- Product code
- PLS
- Decision date
- 2016-12-01
- Classification
- Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Approval order statement
- Approval for the DakoLink software version 4.1 update for the PD-L1 IHC 28-8 pharmDx (melanoma indication).
Current openFDA PMA Record#
- Device
- PD-L1 IHC 28-8 PHARMDX (Melanoma Indication)
- Applicant
- Dako North America, Inc.
- PMA number
- P150027
- Supplement
- S002
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2016-12-01
- Decision code
- APPR
- Date received
- 2016-08-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the DakoLink software version 4.1 update for the PD-L1 IHC 28-8 pharmDx (melanoma indication).