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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, yeast
510(k) Number K080719
Device Name YEAST TRAFFIC LIGHT PNA FISH
Original Applicant
ADVANDX, INC.
10a roessler road
woburn,  MA  01801
Original Contact henrik stender
Regulation Number866.2660
Classification Product Code
JXB  
Date Received03/14/2008
Decision Date 09/12/2008
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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