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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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21 to 30 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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DIASORIN ETI-EBK PLUS ASSAY DIASORIN, INC. P990043 S021 06/08/2016
ABBOTT ARCHITECT AUSAB ABBOTT LABORATORIES INC P050051 S031 07/13/2016
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
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
ELECSYS HBEAG IMMUNOASSAY ROCHE DIAGNOSTICS OPERATIONS I P130015 S005 08/08/2016
ELECSYS HBSAG IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P990012 S024 08/08/2016
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