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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 5 of 5 Results
productcode MZP PMA Number p Decision Date From 1/1/2007 Decision Date To 1/1/2008
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PMA
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VERSANT HCV RNA 3.0 ASSAY (BDNA) SIEMENS HEALTHCARE DIAGNOSTICS P020022 S006 12/14/2007
AMPLICOR HCV TEST VERSION 2.0 Roche Molecular Systems, Inc. P000010 S009 08/30/2007
COBAS AMPLICOR HCV TEST VERSION 2.0 Roche Molecular Systems, Inc. P000012 S013 08/30/2007
BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) SIEMENS HEALTHCARE DIAGNOSTICS P020022 S005 08/01/2007
COBAS AMPLICOR HEPTATIS C VIRUS (HCV) TEST Roche Molecular Systems, Inc. P000012 S012 02/28/2007
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