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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 K082068
Device Name E. COLI PNA FISH
Original Applicant
10a roessler road
woburn,  MA  01801
Original Contact henrik stender
Regulation Number866.2660
Classification Product Code
Date Received07/23/2008
Decision Date 06/25/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No