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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 6 of 6 Results
productcode LOK PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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PMA
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Decision
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Access AFP Reagents on the Access Immunoassay Syst... BECKMAN COULTER, INC. P980041 S050 12/16/2022
IMMULITE® /IMMULITE® 1000 AFP and IMMULITE® 2000 A... SIEMENS HEALTHCARE DIAGNOSTICS P010007 S017 10/14/2022
ARCHITECT AFP / Alinity i AFP Abbott Laboratories P120008 S020 10/12/2022
ADVIA Centaur (XP/XPT, CP) AFP; Atellica IM AFP SIEMENS HEALTHCARE DIAGNOSTICS P930036 S020 09/30/2022
IMMULITE/IMMULITE 1000 AFP, IMMULITE 2000 AFP SIEMENS HEALTHCARE DIAGNOSTICS P010007 S015 03/29/2022
Atellica® IM Alpha Fetoprotein (AFP) Assay SIEMENS HEALTHCARE DIAGNOSTICS P930036 S019 03/29/2022
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