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U.S. Department of Health and Human Services

510(k) Premarket Notification
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81 to 90 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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xpert hemosil factor ii & factor v assay CEPHEID K082118 09/18/2009
xpert gbs lb xc, genexpert dx system, genexpert infinity system Cepheid K203429 05/09/2022
xpert gbs lb genexpert dx systems (gx-i, gx-iv) genexpert dx systems (gx-xvi) genexpert infinity-48 system (900-xxxx) CEPHEID K121539 11/02/2012
xpert flu/rsv xc assay CEPHEID K142045 11/22/2014
xpert flu, genexpert dx systems, genexpert infinity system, genexpert system software verisions 2.1 and 4.0 CEPHEID K103766 04/21/2011
xpert flu+rsv xpress, xpert nasopharyngeal sample collection kit, genexpert xpress system (gx-i) CEPHEID K151226 12/03/2015
xpert flu genexpert dx systems (gx-i, gx-iv) CEPHEID K120911 05/18/2012
xpert flu CEPHEID K123191 12/21/2012
xpert ct/ng, genexpert dx system, genexpert infinity-48s and genexpert infinity-80 systems, genexpert infinity-48 system, xpert vaginal/endocervical specimen collection, xpert urine specimen collection kit, xpert swab specimen collection kit Cepheid K190441 05/23/2019
xpert ct/ng CEPHEID K121710 12/27/2012

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