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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 adalimumab assay
De Novo Number DEN220023
Device Name Procise ADL
Requester
procisedx, inc.
9449 carroll park dr.
san diego,  CA  92121
Contact kurt bray
Regulation Number862.3115
Classification Product Code
QYD  
Date Received04/04/2022
Decision Date 09/29/2023
Decision granted (DENG)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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