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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 10 Results
Product Code: PLS Decision Date from 1/1/2018 Decision Date to 1/1/2019
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Device
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PMA
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ventana pd-l1(sp142) assay VENTANA MEDICAL SYSTEMS, INC. P160002 S007 09/13/2018
ventana pd-l1 (sp263) assay Ventana Medical Systems, Inc. P160046 S005 09/13/2018
pd-l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S011 08/16/2018
ventana pd-l1(sp142) cdx assay VENTANA MEDICAL SYSTEMS, INC. P160002 S006 07/02/2018
pd-l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S009 06/12/2018
ventana pd-l1 (sp263) Ventana Medical Systems, Inc. P160046 S004 06/01/2018
pd-l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S010 04/10/2018
pd-l1 ihc 28-8 pharmdx DAKO NORTH AMERICA, INC. P150025 S009 04/10/2018
pd l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S008 01/22/2018
pd-l1 ihc 28-8 pharmdx DAKO NORTH AMERICA, INC. P150025 S008 01/22/2018
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