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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
Product Code: PLS Decision Date from 1/1/2019 Decision Date to 1/1/2020
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Device
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PMA
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pd-l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S016 07/30/2019
pd-l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S014 06/10/2019
pd-l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S012 04/16/2019
pd-l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S015 03/13/2019
pd-l1 ihc 28-8 pharmdx DAKO NORTH AMERICA, INC. P150025 S011 03/13/2019
ventana pd-l1(sp142) assay. VENTANA MEDICAL SYSTEMS, INC. P160002 S009 03/08/2019
pd-l1 ihc 22c3 pharmdx DAKO NORTH AMERICA, INC. P150013 S013 01/17/2019
pd-l1 ihc 28-8 pharmdx DAKO NORTH AMERICA, INC. P150025 S010 01/17/2019
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