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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name assay, enterovirus nucleic acid
510(k) Number K063261
Device Name NUCLISENS EASYQ ENTEROVIRUS SYSTEM
Original Applicant
BIOMERIEUX, INC.
100 rodolphe st
durham,  NC  27712
Original Contact sandra perreand
Regulation Number866.3225
Classification Product Code
OAI  
Date Received10/30/2006
Decision Date 06/23/2008
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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