QPFClass II
Pediatric Autism Spectrum Disorder Diagnosis Aid
Neurology · 21 CFR 882.1491
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.
MDR events0All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances6All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Earlitec DiagnosticsMar 5, 2026
K253442 · EarliPoint Assessment
- Cognoa, Inc.Apr 11, 2025
K243558 · Canvas Dx
- Earlitec DiagnosticsMar 26, 2025
K243891 · EarliPoint System
- Earlitec Diagnostics, Inc.Jun 29, 2023
K230337 · EarliPoint
- Earlitec Diagnostics, Inc.Jun 8, 2022
K213882 · EarliPoint System
- Cognoa, Inc.Jun 2, 2021
DEN200069 · Cognoa ASD Diagnosis Aid