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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 K121991
Device Name ENTEROCOCCUS QUICKFISH BC
Original Applicant
ADVANDX, INC.
400 tradecenter
suite 6990
woburn,  MA  01801
Original Contact benjamin s crystal
Regulation Number866.3740
Classification Product Code
OAH  
Date Received07/06/2012
Decision Date 01/07/2013
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
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