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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name herpes simplex virus nucleic acid amplification assay
510(k) Number K111527
Model 3711
Device Name MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
Original Applicant
ERAGEN BIOSCIENCES, INC.
918 deming way, suite 201
madison,  WI  53717 1944
Original Contact david lim
Regulation Number866.3305
Classification Product Code
OQO  
Date Received06/06/2011
Decision Date 08/03/2011
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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