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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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71 to 73 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 Anti-HBe Reagent ... ORTHO-CLINICAL DIAGNOSTICS P100001 S013 02/16/2018
Elecsys Anti-HBc II, PreciControl Anti-HBc ROCHE DIAGNOSTICS CORP. P100031 S020 02/09/2018
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ ... ROCHE DIAGNOSTICS, INC. P160019 S003 01/18/2018
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