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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
Device Name MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711
Applicant
ERAGEN BIOSCIENCES
918 DEMING WAY SUITE 201
madison,  WI  53717
Applicant Contact randal vader
Correspondent
ERAGEN BIOSCIENCES
918 DEMING WAY SUITE 201
madison,  WI  53717
Correspondent Contact randal vader
Regulation Number866.3305
Classification Product Code
OQO  
Date Received02/05/2010
Decision Date 05/12/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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