APO-Easy Genotyping kit
FDA 510(k) clearance DEN240032 · decided 2025-06-12
Clearance details
- K-number
- DEN240032
- Device name
- APO-Easy Genotyping kit
- Applicant
- Firalis SA
- Decision
- Unknown
- Date received
- 2024-06-21
- Decision date
- 2025-06-12
- Days to decision
- 356 days
- Clearance type
- Direct
- Product code
- SFC
- Device class
- 2
- Regulation number
- 866.5850
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Huningue, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.