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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 46 Results
productcode LOM PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
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PMA
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ADVIA CENTAUR HBSAGII (HBSII);ADVIA CENTAUR XP HBS... SIEMENS CORP. P110041 S003 10/26/2016
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTR... ROCHE DIAGNOSTICS OPERATIONS I P130015 S007 10/24/2016
ADVIA CENTAUR HEPATITIS B E ANTIGEN ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P090024 S001 10/18/2016
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT ... ORTHO-CLINICAL DIAGNOSTICS P100001 S009 10/10/2016
ADVIA CENTAUR ANTI HBS2 ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P100039 S004 08/20/2016
ADVIA CENTAUR HBC TOTAL ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P040004 S012 08/11/2016
ELECSYS ANTI-HBS IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P010054 S026 08/08/2016
Elecsys Anti-HBc II, PreciControl Anti-HBc ROCHE DIAGNOSTICS CORP. P100031 S014 08/08/2016
ELECSYS ANTI-HBC IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P100032 S011 08/08/2016
ELECSYS ANTI-HBC IGM IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P110022 S015 08/08/2016
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