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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 7 of 7 Results
productcode PLS PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S023 11/23/2021
PD-L1 IHC 28-8 pharmDx Agilent Technologies, Inc. P150025 S014 10/18/2021
VENTANA PD-L1 (SP263) Assay Ventana Medical Systems, Inc. P160046 S010 10/15/2021
VENTANA PD-L1 (SP142) Assay VENTANA MEDICAL SYSTEMS, INC. P160002 S015 09/28/2021
VENTANA PD-LI (SP142) Assay VENTANA MEDICAL SYSTEMS, INC. P160002 S014 05/20/2021
VENTANA PD-LI (SP263) Assay Ventana Medical Systems, Inc. P160046 S009 05/20/2021
PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S021 02/22/2021
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