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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 11 Results
Product Code: PLS Decision Date from 1/1/2016 Decision Date to 1/1/2017
 
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ventana pd-l1(sp142) cdx assay VENTANA MEDICAL SYSTEMS, INC. P160002 S001 12/21/2016
pd-l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S003 12/01/2016
pd-l1 ihc 28-8 pharmdx (non-squamous indication) DAKO NORTH AMERICA, INC. P150025 S002 12/01/2016
pd-l1 ihc 28-8 pharmdx (melanoma indication) DAKO NORTH AMERICA, INC. P150027 S002 12/01/2016
pd-l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S001 10/24/2016
ventana pd-l1 (sp142) assay VENTANA MEDICAL SYSTEMS, INC. P160006 10/18/2016
pd-l1 ihc 28-8 pharmdx (non-squamous nsclc indication) DAKO NORTH AMERICA, INC. P150025 S001 10/05/2016
pd-l1 ihc 28-8 pharmdx (melanoma indication) DAKO NORTH AMERICA, INC. P150027 S001 10/05/2016
pd-l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S002 09/23/2016
ventana pd-l1(sp142) cdx assay VENTANA MEDICAL SYSTEMS, INC. P160002 05/18/2016
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