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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 10 Results
productcode MZO PMA Number p Decision Date From 1/1/2014 Decision Date To 1/1/2015
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PMA
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ARCHITECT ANTI-HCV ABBOTT LABORATORIES INC P050042 S031 12/11/2014
ARCHITECT ANTI-HCV (LN IL79) ABBOTT LABORATORIES INC P050042 S030 10/16/2014
ORAQUICK HCV RAPID ANTIBODY TEST ORASURE TECHNOLOGIES INC. P080027 S018 10/02/2014
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411 ROCHE DIAGNOSTICS CORP. P090007 S012 09/19/2014
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 AND CO... ROCHE DIAGNOSTICS CORP. P090008 S014 09/19/2014
ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS ... ROCHE DIAGNOSTICS CORP. P090009 S012 09/19/2014
ORAQUICK HCV RAPID ANTIBODY TEST ORASURE TECHNOLOGIES INC. P080027 S017 09/02/2014
ORAQUICK HCV RAPID ANTIBODY TEST ORASURE TECHNOLOGIES INC. P080027 S016 07/11/2014
ELECSYS ANTI-HCV ROCHE DIAGNOSTICS CORP. P090008 S013 06/12/2014
ARCHITECT ANTI-HCV ABBOTT LABORATORIES INC P050042 S029 04/28/2014
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