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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode PLS PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S025 11/03/2022
PD-L1 IHC 28-8 pharmDx Agilent Technologies, Inc. P150025 S015 07/22/2022
VENTANA PD-Ll (SP142) Assay VENTANA MEDICAL SYSTEMS, INC. P160002 S017 07/21/2022
VENTANA PD-Ll (SP263) Assay Ventana Medical Systems, Inc. P160046 S012 07/21/2022
VENTANA PD-L1(SP142) Assay VENTANA MEDICAL SYSTEMS, INC. P160002 S016 06/10/2022
VENTANA PD-L1 (SP263) Assay Ventana Medical Systems, Inc. P160046 S011 06/10/2022
PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S024 02/08/2022
PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S022 01/31/2022
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