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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 of 46 Results
productcode LOM PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
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Device
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ELECSYS ANTI-HBC IGM TEST SYSTEM ROCHE DIAGNOSTICS CORP. P110031 S013 02/24/2016
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECI... ROCHE DIAGNOSTICS CORP. P110031 S014 03/16/2016
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECI... ROCHE DIAGNOSTICS CORP. P110031 S015 12/14/2016
ADVIA CENTAUR HBSAGII (HBSII);ADVIA CENTAUR XP HBS... SIEMENS CORP. P110041 S003 10/26/2016
ELECSYS HBEAG IMMUNOASSAY ROCHE DIAGNOSTICS OPERATIONS I P130015 S005 08/08/2016
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTR... ROCHE DIAGNOSTICS OPERATIONS I P130015 S006 03/16/2016
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTR... ROCHE DIAGNOSTICS OPERATIONS I P130015 S007 10/24/2016
ELECSYS HBEAG ROCHE DIAGNOSTICS OPERATIONS I P130015 S008 11/22/2016
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ ... ROCHE DIAGNOSTICS, INC. P160019 12/23/2016
ELECSYS HBSAG IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P990012 S024 08/08/2016
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