510(k) K243891 ยท QPF Pediatric Autism Spectrum Disorder Diagnosis Aid
EarliPoint System
| Applicant | Earlitec Diagnostics, Atlanta GA, US |
| Decision | Substantially Equivalent, Mar 26, 2025 |
| Received | Dec 18, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243891
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.