K243891
- 510(k) number
- K243891
- Device name
- EarliPoint System
- Applicant
- Earlitec Diagnostics GA · US
- Product code
- QPF — Pediatric Autism Spectrum Disorder Diagnosis Aid
- Decision date
- 2025-03-26
- Date received
- 2024-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K243891.pdf
Official FDA record: K243891
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.