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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 infliximab test system
De Novo Number DEN210056
Device Name Procise IFX
ProciseDx Inc.
9449 carroll park drive
san diego,  CA  92121
Contact kurtis r. bray
Regulation Number862.3115
Classification Product Code
Date Received12/08/2021
Decision Date 09/29/2023
Decision granted (DENG)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
Reclassification Order Reclassification Order
Type Direct