Pediatric Autism Spectrum Disorder Diagnosis Aid

QPF · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1491

Classification

FDA Product Code: QPF
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.1491
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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.

Market data

Cleared 510(k) submissions: 6
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown