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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name setmelanotide eligibility gene variant detection system
De Novo Number DEN200059
Device Name POMC/PCSK1/LEPR CDx Panel
PreventionGenetics, LLC
3800 s. business park avenue
marshfield,  WI  54449
Contact jerry machado
Regulation Number862.1164
Classification Product Code
Date Received09/18/2020
Decision Date 01/21/2022
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct