510(k) DEN240032
- Device
- APO-Easy Genotyping kit
- Applicant
- Firalis SA
- 510(k) number
- DEN240032
- Product code
- SFC
- Decision
- Unknown (DENG)
- Decision date
- 2025-06-12
- Date received
- 2024-06-21
- Regulation
- 866.5850
- Classification name
- Neurologic Disease Risk Assessment Molecular Test
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Huseyin Firat
- Address
- 35 Rue Du Fort Huningue FR 68330 68330
FDA Registration Numbers
- 3009523773
Source Documents
510(k) summary PDF not indicated by FDA