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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 127 Results
productcode LOM PMA Number p Decision Date From 1/1/2012 Decision Date To 1/1/2013
 
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VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM Ortho-Clinical Diagnostics, In P030026 S027 12/21/2012
VITROS IMMUNODIAGNOSTIC PRODUCTS ABEAG Ortho-Clinical Diagnostics, In P090028 S006 12/21/2012
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE ORTHO-CLINICAL DIAGNOSTICS P100001 S005 12/21/2012
ELECSYS ANTI-HBS ROCHE DIAGNOSTICS CORP. P010054 S018 12/20/2012
PRECICONTROL ANTI-HBS ROCHE DIAGNOSTICS CORP. P010054 S021 12/20/2012
ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170 ROCHE DIAGNOSTICS CORP. P100031 S005 12/20/2012
PRECICONTROL ANTI-HBC (MODULAR ANALYTICS E170) ROCHE DIAGNOSTICS CORP. P100031 S010 12/20/2012
ELECSYS ANTI-HBC ON ELECSYS 2010 ROCHE DIAGNOSTICS CORP. P100032 S005 12/20/2012
PRECICONTROL ANTI-HBC (ELECSYS) 2010 ROCHE DIAGNOSTICS CORP. P100032 S008 12/20/2012
ELECSYS ANTI-HBC IGM ON COBAS E 601 ROCHE DIAGNOSTICS CORP. P110022 S002 12/20/2012
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