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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
Applicant
BIOMERIEUX, INC.
100 RODOLPHE ST
DURHAM,  NC  27712
Applicant Contact SANDRA PERREAND
Correspondent
BIOMERIEUX, INC.
100 RODOLPHE ST
DURHAM,  NC  27712
Correspondent Contact SANDRA PERREAND
Regulation Number866.3225
Classification Product Code
OAI  
Date Received10/30/2006
Decision Date 06/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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