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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 73 Results
productcode LOM PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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PMA
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VITROS Immunodiagnostic Products Anti-HBe Reagent ... ORTHO-CLINICAL DIAGNOSTICS P100001 S014 07/02/2018
VITROS Immunodiagnostic Products Anti-HBe Reagent ... ORTHO-CLINICAL DIAGNOSTICS P100001 S015 12/17/2018
Vitros Immunodiagnostic Products Anti-HBe Reagent ... ORTHO-CLINICAL DIAGNOSTICS P100001 S013 02/16/2018
VITROS Immunodiagnostic Products Anti-HBc Reagent ... ORTHO-CLINICAL DIAGNOSTICS P030024 S027 10/16/2018
VITROS Immunodiagnostic Products Anti-HBc Reagent ... ORTHO-CLINICAL DIAGNOSTICS P030024 S026 07/02/2018
VITROS Immunodiagnostic Products Anti-HBc Reagent ... ORTHO-CLINICAL DIAGNOSTICS P030024 S025 07/02/2018
VITROS Immunodiagnostic Products Anti-HBc Reagent ... ORTHO-CLINICAL DIAGNOSTICS P030024 S028 12/17/2018
VITROS Immunodiagnostic Products Anti-HBc IgM Reag... Ortho-Clinical Diagnostics, In P030026 S032 07/02/2018
VITROS Immunodiagnostic Products Anti-HBc IgM Reag... Ortho-Clinical Diagnostics, In P030026 S034 07/02/2018
VITROS Immunodiagnostic Products Anti-HBc IgM Reag... Ortho-Clinical Diagnostics, In P030026 S035 12/17/2018
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