K253442
- 510(k) number
- K253442
- Device name
- EarliPoint Assessment
- Applicant
- Earlitec Diagnostics MN · US
- Product code
- QPF — Pediatric Autism Spectrum Disorder Diagnosis Aid
- Decision date
- 2026-03-05
- Date received
- 2025-10-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253442.pdf
Official FDA record: K253442
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.