PMA P150027S003
- Device
- PD-L1 IHC 28-8 PHARMDX
- Applicant
- Dako North America, Inc.
- PMA number
- P150027
- Supplement
- S003
- Product code
- PLS
- Decision date
- 2017-02-24
- Classification
- Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Approval order statement
- Approval for the updated product labeling and associated data.
Current openFDA PMA Record#
- Device
- PD-L1 IHC 28-8 PHARMDX
- Applicant
- Dako North America, Inc.
- PMA number
- P150027
- Supplement
- S003
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2017-02-24
- Decision code
- APPR
- Date received
- 2016-08-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the updated product labeling and associated data.