6 devices · 5 companies · 2021 to 2026
Product code QPF: Pediatric Autism Spectrum Disorder Diagnosis Aid
6 devices under product code QPF, 2021 to 2026, from 5 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (6 of 6 here), the regulation, and MAUDE report counts by product code.
Pediatric Autism Spectrum Disorder Diagnosis Aid. 21 CFR 882.1491, Class II. A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| EarliPoint AssessmentK253442 · 510(k) | Earlitec Diagnostics | Neurology | database entry | |
| Canvas DxK243558 · 510(k) | Cognoa, Inc. | Neurology | database entry | |
| EarliPoint SystemK243891 · 510(k) | EarliTec Diagnostics | Neurology | database entry | |
| EarliPointK230337 · 510(k) | EarliTec Diagnostics, Inc | Neurology | database entry | |
| EarliPoint SystemK213882 · 510(k) | EarliTec Diagnostics, Inc. | Neurology | database entry | |
| Cognoa ASD Diagnosis AidDEN200069 · De Novo | Cognoa, Inc. | Neurology | database entry |
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