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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode LOK PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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PMA
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ARCHITECT AFP / Alinity i AFP Abbott Laboratories P120008 S019 12/17/2021
ARCHITECT AFP (LN 3P36) Abbott Laboratories P120008 S018 12/06/2021
Atellica® IM Alpha Fetoprotein (AFP) Assay SIEMENS HEALTHCARE DIAGNOSTICS P930036 S018 11/09/2021
Atellica® IM Alpha Fetoprotein (AFP) Assay SIEMENS HEALTHCARE DIAGNOSTICS P930036 S017 08/25/2021
AutoDELFIA hAFP Test System PerkinElmer, Inc. P970037 S012 08/11/2021
IMMULITE/IMMULITE 1000 AFP SIEMENS HEALTHCARE DIAGNOSTICS P010007 S014 04/28/2021
Atellica IM Alpha Fetoprotein (AFP) Assay SIEMENS HEALTHCARE DIAGNOSTICS P930036 S016 04/27/2021
ARCHITECT AFP Reagents, Alinity i AFP Reagent Kit Abbott Laboratories P120008 S017 04/22/2021
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