PMA P150013S007
- Device
- PD-L1 IHC 22C3 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P150013
- Supplement
- S007
- Product code
- PLS
- Decision date
- 2017-11-20
- Classification
- Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Approval order statement
- Approved for labeling changes to include results from additional non-clinical studies.
Current openFDA PMA Record#
- Device
- PD-L1 IHC 22C3 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P150013
- Supplement
- S007
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2017-11-20
- Decision code
- APPR
- Date received
- 2017-09-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approved for labeling changes to include results from additional non-clinical studies.