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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fish (fluorescent in situ hybridization) kit, protein nucleic acid, enterococcus faecalis
510(k) Number K083074
Device Name AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
Original Applicant
ADVANDX, INC.
10a roessler road
woburn,  MA  01801
Original Contact paula e bulger
Regulation Number866.3740
Classification Product Code
OAH  
Date Received11/11/2008
Decision Date 07/24/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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