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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode MZO PMA Number p Decision Date From 1/1/2009 Decision Date To 1/1/2010
 
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ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HCV SIEMENS HEALTHCARE DIAGNOSTICS P030056 S005 08/20/2009
ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HCV SIEMENS HEALTHCARE DIAGNOSTICS P030056 S006 08/19/2009
ADVIA CENTAUR HCV ON CENTAUR CP SIEMENS HEALTHCARE DIAGNOSTICS P030056 S002 08/13/2009
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT ... Ortho-Clinical Diagnostics, In P010021 S016 07/15/2009
ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV) Abbott Laboratories P970027 S007 07/08/2009
ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL ABBOTT LABORATORIES INC P050042 S005 06/23/2009
ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONT... SIEMENS HEALTHCARE DIAGNOSTICS P030056 S004 04/09/2009
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT ... Ortho-Clinical Diagnostics, In P010021 S015 03/19/2009
ADVIA CENTAUR HCV SIEMENS HEALTHCARE DIAGNOSTICS P030056 S003 03/04/2009
ABBOTT ARCHITECT ANTI-HCV ABBOTT LABORATORIES INC P050042 S004 01/28/2009
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