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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name kit, identification, enterobacteriaceae
510(k) Number K081433
Device Name EK/P. AERUGINOSA PNA FISH
Original Applicant
ADVANDX, INC.
10a roessler road
woburn,  MA  01801
Original Contact henrik stender
Regulation Number866.2660
Classification Product Code
JSS  
Date Received09/03/2008
Decision Date 03/26/2009
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
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