PMA P150013S022

Device: PD-L1 IHC 22C3 pharmDx
Applicant: Agilent Technologies, Inc.
Product code: PLS
Decision date: 2022-01-31
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Approval order statement: Approval of the final report for the External Reproducibility Study (Part B – Inter-Observer) using the PD-L1 IHC 22C3 pharmDx in esophogeal squamous cell carcinoma specimens and the proposed changes to the labeling to include the results of this study.

Current openFDA PMA Record#

Device: PD-L1 IHC 22C3 pharmDx
Applicant: Agilent Technologies, Inc.
PMA number: P150013
Supplement: S022
Product code: PLS
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date: 2022-01-31
Decision code: APPR
Date received: 2020-11-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval of the final report for the External Reproducibility Study (Part B – Inter-Observer) using the PD-L1 IHC 22C3 pharmDx in esophogeal squamous cell carcinoma specimens and the proposed changes to the labeling to include the results of this study.