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U.S. Department of Health and Human Services

510(k) Premarket Notification
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31 to 40 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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xw-100 automated hematology analyzer for clia waived use Sysmex America, Inc. K172604 11/06/2017
xtag respiratory viral panel, xtag data analysis software (tdas rvp-1) LUMINEX MOLECULAR DIAGNOSTICS, INC. K112199 09/01/2011
xtag respiratory viral panel, models i019a0110, i019c011, i019d0112, i019e0113, s019-0116 LUMINEX MOLECULAR DIAGNOSTICS, INC. K091667 06/25/2009
xtag respiratory viral panel fast, xtag data analysis software for rvp fast LUMINEX MOLECULAR DIAGNOSTICS, INC. K103776 07/01/2011
xtag respiratory viral panel LUMINEX MOLECULAR DIAGNOSTICS, INC. K081483 06/25/2008
xtag gastrointestinal pathogen panel(gpp)/xtag data analysis software for gpp(tdas gpp) LUMINEX MOLECULAR DIAGNOSTICS, INC. K140647 10/24/2014
xtag gastrointestinal pathogen panel(gpp) xtag data analysis software for gpp (tdas gpp) luminex magpix LUMINEX MOLECULAR DIAGNOSTICS, INC. K121894 03/21/2013
xtag gastrointestinal pathogen panel (gpp)/xtag data analysis software for gpp (tdas gpp) LUMINEX MOLECULAR DIAGNOSTICS, INC. K140377 09/16/2014
xtag gastrointestinal pathogen panel (gpp), xtag data analysis software (tdas gpp) Luminex Molecular Diagnostics, Inc. K183023 11/30/2018
xtag gastrointestinal pathogen panel (gpp), xtag data analysis software (tdas gpp) Luminex Molecular Diagnostics, Inc. K183030 11/30/2018

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