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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
ProciseDx Inc.
9449 carroll park drive
san diego,  CA  92121
Contact kurt bray
Regulation Number862.3115
Classification Product Code
Date Received04/04/2022
Decision Date 09/29/2023
Decision granted (DENG)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
Reclassification Order Reclassification Order
Type Direct