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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 14 Results
productcode PLS PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S007 11/20/2017
PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S006 09/22/2017
PD-L1 IHC 28-8 PHARMDX Agilent Technologies, Inc. P150025 S003 09/15/2017
Ventana PD-L1 (SP142) Assay VENTANA MEDICAL SYSTEMS, INC. P160002 S003 08/04/2017
Ventana PD-L1 (SP263) Assay Ventana Medical Systems, Inc. P160046 S001 08/04/2017
Ventana PD-L1 (SP142) Assay VENTANA MEDICAL SYSTEMS, INC. P160002 S002 06/06/2017
PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S005 05/16/2017
PD-L1 IHC 28-8 pharmDx Agilent Technologies, Inc. P150025 S006 05/16/2017
PD-L1 IHC 28-8 pharmDx Agilent Technologies, Inc. P150025 S005 05/03/2017
VENTANA PD-L1 (SP263) ASSAY Ventana Medical Systems, Inc. P160046 05/01/2017
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