Home / 510(k) Clearances / DEN220023

510(k) DEN220023

Procise ADL by Procisedx, Inc. — Product Code QYD

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: September 29, 2023
Date Received: April 4, 2022
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Adalimumab Assay
Device Class: Class II
Regulation Number: 862.3115
Review Panel: TX
Submission Type

An in vitro diagnostic device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody