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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: NJR Applicant: CEPHEID Decision Date To: 08/01/2014
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xpert gbs lb genexpert dx systems (gx-i, cepheid K121539 11/02/2012
smart gbs and smartcycle dx system and s cepheid K062948 12/08/2006
xpert, genexpert dx system cepheid K060540 07/25/2006
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