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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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PMA Number P160019 Decision Date To 05/21/2024
 
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Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ ... ROCHE DIAGNOSTICS, INC. P160019 12/23/2016
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ ... ROCHE DIAGNOSTICS, INC. P160019 S001 11/01/2017
Elecsys HBsAg II (100/200 tests) Immunoassay ROCHE DIAGNOSTICS, INC. P160019 S002 06/23/2017
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ ... ROCHE DIAGNOSTICS, INC. P160019 S003 01/18/2018
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ ... ROCHE DIAGNOSTICS, INC. P160019 S004 12/29/2017
Elecsys HBsAg II ROCHE DIAGNOSTICS, INC. P160019 S005 08/31/2017
Elecsys HBsAg II ROCHE DIAGNOSTICS, INC. P160019 S006 12/20/2017
Elecsys HBsAg II ROCHE DIAGNOSTICS, INC. P160019 S007 06/13/2018
Elecsys HBsAg II (100/200 tests) ROCHE DIAGNOSTICS, INC. P160019 S008 11/06/2018
Elecsys HBsAg II ROCHE DIAGNOSTICS, INC. P160019 S009 04/24/2019
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