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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 of 73 Results
productcode LOM PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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VITROS Immunodiagnostic Products HBeAg Reagent Pac... Ortho-Clinical Diagnostics, In P090028 S013 07/02/2018
HBeAg Reagent Pack and Calibrator Ortho-Clinical Diagnostics, In P090028 S014 02/16/2018
VITROS Immunodiagnostic Products HBeAg Reagent Pac... Ortho-Clinical Diagnostics, In P090028 S015 07/02/2018
VITROS Immunodiagnostic Products HBeAg Reagent Pac... Ortho-Clinical Diagnostics, In P090028 S016 12/17/2018
VITROS Immunodiagnostic Products Anti-HBe Reagent ... ORTHO-CLINICAL DIAGNOSTICS P100001 S012 07/02/2018
Vitros Immunodiagnostic Products Anti-HBe Reagent ... ORTHO-CLINICAL DIAGNOSTICS P100001 S013 02/16/2018
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
Elecsys Anti-HBc II, PreciControl Anti-HBc ROCHE DIAGNOSTICS CORP. P100031 S020 02/09/2018
Elecsys Anti-HBc II ROCHE DIAGNOSTICS CORP. P100031 S023 04/20/2018
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