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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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Device
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PMA
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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
ABBOTT ARCHITECT AUSAB ABBOTT LABORATORIES INC P050051 S031 07/13/2016
ETI-MAK-2 PLUS ASSAY AND HBsAg CONFIRMATORY TEST A... DIASORIN, INC. P990038 S021 06/08/2016
ETI-AB-AUK PLUS ASSAY DIASORIN, INC. P990042 S017 06/08/2016
DIASORIN ETI-EBK PLUS ASSAY DIASORIN, INC. P990043 S021 06/08/2016
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMAT... Abbott Laboratories P110029 S023 04/06/2016
VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PAC... Ortho-Clinical Diagnostics, In P000044 S034 03/30/2016
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