DEN240032
- 510(k) number
- DEN240032
- Device name
- APO-Easy Genotyping kit
- Applicant
- Firalis SA FR
- Product code
- SFC — Neurologic Disease Risk Assessment Molecular Test
- Decision date
- 2025-06-12
- Date received
- 2024-06-21
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Immunology
Official FDA record: DEN240032
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.