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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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Elecsys ANti-HBs ROCHE DIAGNOSTICS CORP. P010054 S039 11/06/2018
Elecsys Anti-HBc II ROCHE DIAGNOSTICS CORP. P100031 S025 11/06/2018
Elecsys Anti-HBc II ROCHE DIAGNOSTICS CORP. P100032 S019 11/06/2018
Elecsys Anti-HBc IgM ROCHE DIAGNOSTICS CORP. P110022 S026 11/06/2018
Elecsys Anti-HBc IgM ROCHE DIAGNOSTICS CORP. P110025 S022 11/06/2018
Elecsys Anti-HBc IgM ROCHE DIAGNOSTICS CORP. P110031 S023 11/06/2018
Elecsys HBeAg ROCHE DIAGNOSTICS OPERATIONS I P130015 S016 11/06/2018
Elecsys HBsAg II (100/200 tests) ROCHE DIAGNOSTICS, INC. P160019 S008 11/06/2018
VITROS Immunodiagnostic Products Anti-HBc Reagent ... ORTHO-CLINICAL DIAGNOSTICS P030024 S027 10/16/2018
Atellica IM Hepatitis B core IgM (aHBcM) SIEMENS HEALTHCARE DIAGNOSTICS P030040 S013 09/11/2018
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