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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 1/1/2017 Decision Date To 1/1/2018
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PMA
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Access AFP Immunoassay BECKMAN COULTER, INC. P980041 S039 10/24/2017
Access AFP Reagents on the Access Immunoassy Syste... BECKMAN COULTER, INC. P980041 S037 07/07/2017
Access AFP Reagents on the Access Immunoassay Syst... BECKMAN COULTER, INC. P980041 S036 06/16/2017
AutoDELFIA hAFP Test System PerkinElmer, Inc. P970037 S010 06/07/2017
ADVIA CENTAUR IMMUNOASSAY SIEMENS HEALTHCARE DIAGNOSTICS P930036 S007 04/26/2017
ACCESS AFP CALIBRATORS ON THE ACCESS IMMUNOASSAY A... BECKMAN COULTER, INC. P980041 S035 02/14/2017
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