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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 5 of 5 Results
ProductCode: NJR Applicant: CEPHEID Decision Date To: 11/28/2014
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xpert® xpress gbs, genexpert® dx system, genexpert® infinity systems Cepheid K222638 09/27/2023
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
smart gbs and smartcycle dx system and software, version 1.7b CEPHEID K062948 12/08/2006
xpert, genexpert dx system CEPHEID K060540 07/25/2006
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