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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 K100336
Model 3711
Device Name MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711
Original Applicant
ERAGEN BIOSCIENCES
918 deming way suite 201
madison,  WI  53717
Original Contact randal vader
Regulation Number866.3305
Classification Product Code
OQO  
Date Received02/05/2010
Decision Date 05/12/2010
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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