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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 16 Results
productcode MZO PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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Elecsys Anti-HCV Immunoassay ROCHE DIAGNOSTICS CORP. P090007 S017 12/20/2017
Elecsys Anti-HCV Immunoassay ROCHE DIAGNOSTICS CORP. P090008 S019 12/20/2017
Elecsys Anti-HCV Immunoassay ROCHE DIAGNOSTICS CORP. P090009 S017 12/20/2017
Elecsys Anti-HCV II ROCHE DIAGNOSTICS OPERATIONS I P140021 S012 12/20/2017
Elecsys Anti-HCV II, PreciControl Anti-HCV ROCHE DIAGNOSTICS OPERATIONS I P140021 S010 11/03/2017
OraQuick HCV Rapid Antibody Test ORASURE TECHNOLOGIES INC. P080027 S030 09/27/2017
OraQuick HCV Rapid Antibody Test ORASURE TECHNOLOGIES INC. P080027 S029 09/07/2017
Elecsys Anit-HCV ROCHE DIAGNOSTICS CORP. P090007 S016 08/31/2017
Elecsys Anit-HCV ROCHE DIAGNOSTICS CORP. P090008 S018 08/31/2017
Elecsys Anit-HCV ROCHE DIAGNOSTICS CORP. P090009 S016 08/31/2017
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