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U.S. Department of Health and Human Services

510(k) Premarket Notification
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41 to 50 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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xtag gastrointestinal pathogen panel (gpp), xtag data analysis software (tdas gpp) Luminex Molecular Diagnostics, Inc. K191160 11/04/2019
xtag gastrointestinal pathogen panel (gpp) Luminex Molecular Diagnostics, Inc. K191161 11/12/2019
xtag cystic fibrosis 60 kit v2, xtag data analysis software (tdas) cftr Luminex Molecular Diagnostics, Inc. K163336 12/15/2016
xtag cystic fibrosis 39 kit v2, (cftr 39 kit v2), model i027c0231, i027d0266, i027e0267 LUMINEX MOLECULAR DIAGNOSTICS, INC. K083846 09/01/2009
xtag cystic fibrosis 39 kit v2 Luminex Molecular Diagnostics, Inc. K163347 12/15/2016
xtag cyp2d6 kit v3, model i030c0300 (96 tests/kit), tdas cyp2d6 software (2030-0254) LUMINEX MOLECULAR DIAGNOSTICS, INC. K093420 08/26/2010
xtag cyp2d6 kit v3 (including tdas cyp2d6 software) LUMINEX MOLECULAR DIAGNOSTICS, INC. K130189 05/21/2013
xtag cyp2d6 kit v3 Luminex Molecular Diagnostics, Inc. K170492 08/11/2017
xtag cyp2c19 kit v3 LUMINEX MOLECULAR DIAGNOSTICS, INC. K131565 09/11/2013
xtag cf60 kit v2 LUMINEX MOLECULAR DIAGNOSTICS, INC. K083845 12/11/2009

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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