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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 9 of 9 Results
productcode LOK PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
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ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur... SIEMENS HEALTHCARE DIAGNOSTICS P930036 S022 12/18/2023
ARCHITECT AFP / Alinity i AFP Abbott Laboratories P120008 S027 12/14/2023
Alinity i AFP Reagent Kit Abbott Laboratories P120008 S026 11/08/2023
ARCHITECT AFP, Alinity i AFP Abbott Laboratories P120008 S022 10/11/2023
Alinity i AFP Abbott Laboratories P120008 S025 09/25/2023
IMMULITE® AFP, IMMULITE® 2000 AFP SIEMENS HEALTHCARE DIAGNOSTICS P010007 S016 08/30/2023
ARCHITECT AFP / Alinity i AFP Abbott Laboratories P120008 S024 07/10/2023
ARCHITECT AFP, Alinity i AFP Abbott Laboratories P120008 S023 06/22/2023
ARCHITECT AFP / Alinity i AFP Abbott Laboratories P120008 S021 01/30/2023
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