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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: OAH Applicant: ADVANDX, INC Decision Date To: 06/27/2016
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enterococcus quickfish bc ADVANDX, INC. K121991 01/07/2013
avandx e. faecalis/oe pna fish culture identification kit ADVANDX, INC. K083074 07/24/2009
gbs pna fish ADVANDX, INC. K082612 05/05/2009
enterococcus faecalis pna fish ADVANDX, INC. K063127 12/22/2006
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