510(k) K253442 ยท QPF Pediatric Autism Spectrum Disorder Diagnosis Aid
EarliPoint Assessment
| Applicant | Earlitec Diagnostics, Plymouth MN, US |
| Decision | Substantially Equivalent, Mar 5, 2026 |
| Received | Oct 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253442
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.