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U.S. Department of Health and Human Services

510(k) Premarket Notification

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71 to 80 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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xpert norovirus, genexpert dx systems (gx-i, gx-11, gx-iv, gx-xvi), genexpert infinity-48 system, genexpert infinity-48s system, genexpert infinity-80 system CEPHEID K142501 11/26/2014
xpert mtb/rif assay, genexpert dx, genexpert infinity-48, genexpert infinity-48s, genexpert infinity-80 CEPHEID K143302 02/12/2015
xpert mrsa/sa ssti assay CEPHEID K080837 09/24/2008
xpert mrsa/sa nasal assay CEPHEID K100822 06/01/2010
xpert mrsa/sa blood culture, genexpert dx system, genexpert infinity-48s system, genexpert infinity-80 system Cepheid K190771 04/25/2019
xpert mrsa/sa blood culture assay; genexpert dx systems (gx-i, gx-ii, gx-iv, gx-xvi); genexpert infinity-48 system; gene CEPHEID K130894 06/20/2013
xpert mrsa/sa blood culture assay CEPHEID K082140 09/29/2008
xpert mrsa/sa bc (blood culture) assay model gxmrsa/sa-bc-10 CEPHEID K101879 07/28/2010
xpert mrsa nxg CEPHEID K162444 11/23/2016
xpert mrsa CEPHEID K070462 04/17/2007

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