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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 1/1/2015 Decision Date To 1/1/2016
 
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HOME ACCESS HEPATITIS C CHECK PWNHealth Chicago LLC P980046 S009 12/09/2015
ELECSYS ANTI-HCV ROCHE DIAGNOSTICS CORP. P090007 S013 11/24/2015
ELECSYS ANTI-HCV ROCHE DIAGNOSTICS CORP. P090008 S015 11/24/2015
ELECSYS ANTI-HCV ROCHE DIAGNOSTICS CORP. P090009 S013 11/24/2015
ELECSYS ANTI-HCV II ROCHE DIAGNOSTICS OPERATIONS I P140021 S001 11/24/2015
ORAQUICK HCV RAPID ANTIBODY TEST ORASURE TECHNOLOGIES INC. P080027 S021 10/15/2015
VITROS ANTI-HCV ASSAY Ortho-Clinical Diagnostics, In P010021 S027 09/08/2015
ARCHITECT ANTI-HCV (LN 1L79) ABBOTT LABORATORIES INC P050042 S032 08/13/2015
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT ... Ortho-Clinical Diagnostics, In P010021 S026 07/23/2015
ADVIA CENTAUR HCV ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P030056 S010 07/10/2015
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