510(k) DEN240032

APO-Easy Genotyping kit by Firalis SA — Product Code SFC

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: June 12, 2025
Date Received: June 21, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Neurologic Disease Risk Assessment Molecular Test
Device Class: Class II
Regulation Number: 866.5850
Review Panel: IM
Submission Type

A neurologic disease predisposition risk assessment system is a prescription in vitro diagnostic device intended to detect or measure DNA, RNA, or protein variants in human specimens. The measurements aid in the evaluation of the risk of developing a neurologic disease in patients presenting with symptoms and/or with disease-associated risk factors to aid in patient management, in conjunction with other laboratory and clinical information.