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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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ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICON... ROCHE DIAGNOSTICS CORP. P110025 S015 03/16/2016
ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICON... ROCHE DIAGNOSTICS CORP. P110025 S016 12/14/2016
ELECSYS ANTI-HBC IGM IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P110022 S015 08/08/2016
ELECSYS ANTI-HBC IGM IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P110025 S013 08/08/2016
ELECSYS ANTI-HBC IGM IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P110031 S012 08/08/2016
DIASORIN ETI-EBK PLUS ASSAY DIASORIN, INC. P990043 S021 06/08/2016
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMAT... Abbott Laboratories P110029 S023 04/06/2016
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMAT... Abbott Laboratories P110029 S024 11/10/2016
ADVIA CENTAUR HEPATITIS B E ANTIGEN ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P090024 S001 10/18/2016
ADVIA CENTAUR HBSAGII (HBSII);ADVIA CENTAUR XP HBS... SIEMENS CORP. P110041 S003 10/26/2016
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