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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 1/1/2010 Decision Date To 1/1/2011
 
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AXSYM ANTI-HCV (LN 5C36) Abbott Laboratories P970027 S010 10/19/2010
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTR... ROCHE DIAGNOSTICS CORP. P090007 S001 09/23/2010
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTR... ROCHE DIAGNOSTICS CORP. P090008 S001 09/23/2010
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTR... ROCHE DIAGNOSTICS CORP. P090009 S001 09/23/2010
AXSYM ANTI-HCV Abbott Laboratories P970027 S009 09/20/2010
ANTI-HCV REAGENT PACK AND CALIBRATOR Ortho-Clinical Diagnostics, In P010021 S017 07/16/2010
ORAQUICK HCV RAPID ANTIBODY TEST ORASURE TECHNOLOGIES INC. P080027 06/25/2010
VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HCV REAGENT P... Ortho-Clinical Diagnostics, In P010021 S018 05/20/2010
ABBOTT AXSYM ANTI-HCV Abbott Laboratories P970027 S008 05/13/2010
ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL... ROCHE DIAGNOSTICS CORP. P090007 04/29/2010
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