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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 15 Results
productcode LOK PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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Access AFP Reagents on the Access Immunoassay Syst... BECKMAN COULTER, INC. P980041 S049 12/16/2020
ARCHITECT AFP and Alinity i AFP Abbott Laboratories P120008 S016 11/05/2020
Access AFP Reagents on the Access Immunoassay Syst... BECKMAN COULTER, INC. P980041 S048 10/16/2020
Access AFP Reagents on the Access Immunoassay Syst... BECKMAN COULTER, INC. P980041 S047 10/07/2020
IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULI... SIEMENS HEALTHCARE DIAGNOSTICS P010007 S013 09/08/2020
ADVIA Centaur AFP Readypack Reagents SIEMENS HEALTHCARE DIAGNOSTICS P930036 S015 08/25/2020
IMMULITE/IMMULITE 1000/IMMULITE 2000 AFP SIEMENS HEALTHCARE DIAGNOSTICS P010007 S012 08/18/2020
Advia Centaur AFP Immunoassay and Atellica IM AFP ... SIEMENS HEALTHCARE DIAGNOSTICS P930036 S012 07/02/2020
Alinity i AFP Reagent Kit Abbott Laboratories P120008 S013 06/05/2020
Acess AFP Reagents on the Access Immunoassay Syste... BECKMAN COULTER, INC. P980041 S043 05/28/2020
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