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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 73 Results
productcode LOM PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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Atellica IM anti-HBc Total (HBcT) SIEMENS HEALTHCARE DIAGNOSTICS P040004 S014 09/11/2018
Atellica IM Hepatitis B e Antigen (HBeAg) SIEMENS HEALTHCARE DIAGNOSTICS P090024 S005 09/11/2018
Atellica IM Anti-Hepatitis B Surface Antigen 2 (aH... SIEMENS HEALTHCARE DIAGNOSTICS P100039 S006 09/11/2018
Atellica IM HBsAgII (HBsII)/Atellica IM HBsAg Conf... SIEMENS CORP. P110041 S006 09/11/2018
Atellica IM Hepatitis B core IgM (aHBcM) assay; At... SIEMENS HEALTHCARE DIAGNOSTICS P030040 S014 08/24/2018
ARCHITECT CORE, LN 6L22 Abbott Laboratories P080023 S029 08/09/2018
ARCHITECT HBsAG Qualitative Reagent Kit (100/500 T... Abbott Laboratories P110029 S027 07/18/2018
Elecsys Ani-HBs, PreciControl Anti-HBs and Anti-HB... ROCHE DIAGNOSTICS CORP. P010054 S037 07/13/2018
Atellica IM Hepatitis B e Antigen (HBeAg) SIEMENS HEALTHCARE DIAGNOSTICS P090024 S004 07/12/2018
Atellica IM Anti-Hepatitis B core Total (HBcT), At... SIEMENS HEALTHCARE DIAGNOSTICS P040004 S013 07/06/2018
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