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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 1/1/2018 Decision Date To 1/1/2019
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PMA
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IMMULITE/IMMULITE 1000 AFP and IMMULITE 2000 AFP SIEMENS HEALTHCARE DIAGNOSTICS P010007 S010 12/27/2018
Acess AFP Reagents on the Access Immunoassay Syste... BECKMAN COULTER, INC. P980041 S041 12/21/2018
ARCHITECT AFP assay Abbott Laboratories P120008 S012 12/13/2018
Atellica IM Alpha Fetoprotein (AFP) SIEMENS HEALTHCARE DIAGNOSTICS P930036 S009 10/25/2018
Access AFP Reagents on the Access Immunoassay Syst... BECKMAN COULTER, INC. P980041 S040 09/12/2018
AutoDELFIA hAFP Test Kit PerkinElmer, Inc. P970037 S011 09/06/2018
Atellica IM Alpha Fetoprotein (AFP) SIEMENS HEALTHCARE DIAGNOSTICS P930036 S008 05/04/2018
ADVIA CENTAUR AFP ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P930036 S006 04/13/2018
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