PMA P150025
- Device
- PD-L1 IHC 28-8 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P150025
- Supplement
- S015
- Product code
- PLS
- Decision date
- 2025-06-27
- Generic name
- Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1
- Approval order statement
- approval for incorporating a fill-volume tolerance range and software into a vial-filling process
Current openFDA PMA Record#
- Device
- PD-L1 IHC 28-8 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P150025
- Supplement
- S017
- Decision date
- 2025-06-27
- Decision code
- OK30
- Date received
- 2025-04-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for incorporating a fill-volume tolerance range and software into a vial-filling process