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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
Product Code: PLS Decision Date from 1/1/2017 Decision Date to 1/1/2018
 
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pd-l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S007 11/20/2017
pd-l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S006 09/22/2017
pd-l1 ihc 28-8 pharmdx DAKO NORTH AMERICA, 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 DAKO NORTH AMERICA, INC. P150013 S005 05/16/2017
pd-l1 ihc 28-8 pharmdx DAKO NORTH AMERICA, INC. P150025 S006 05/16/2017
pd-l1 ihc 28-8 pharmdx DAKO NORTH AMERICA, INC. P150025 S005 05/03/2017
ventana pd-l1 (sp263) assay Ventana Medical Systems, Inc. P160046 05/01/2017
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