PMA P150025S010
- Device
- PD-L1 IHC 28-8 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P150025
- Supplement
- S010
- Product code
- PLS
- Decision date
- 2019-01-17
- Classification
- Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Approval order statement
- Implementation of an in-process QC specification.
Current openFDA PMA Record#
- Device
- PD-L1 IHC 28-8 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P150025
- Supplement
- S010
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2019-01-17
- Decision code
- OK30
- Date received
- 2018-12-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an in-process QC specification.