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510(k) DEN200069

Cognoa ASD Diagnosis Aid by Cognoa, Inc. — Product Code QPF

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
June 2, 2021
Date Received
November 3, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pediatric Autism Spectrum Disorder Diagnosis Aid
Device Class
Class II
Regulation Number
882.1491
Review Panel
NE
Submission Type

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.

Other clearances by Cognoa, Inc.

  • K243558 — Canvas Dx (April 11, 2025)

Other clearances for product code QPF

  • K253442 — EarliPoint Assessment (March 5, 2026)
  • K243558 — Canvas Dx (April 11, 2025)
  • K243891 — EarliPoint System (March 26, 2025)
  • K230337 — EarliPoint (June 29, 2023)
  • K213882 — EarliPoint System (June 8, 2022)