510(k) DEN240032
DEN240032 is an FDA 510(k) premarket notification submitted by Firalis SA for the device "APO-Easy Genotyping kit". The FDA issued a decision of De Novo Granted on June 12, 2025. The device falls under product code SFC (Neurologic Disease Risk Assessment Molecular Test), a Class II device regulated under 21 CFR 866.5850.
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.