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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pediatric Autism Spectrum Disorder Diagnosis Aid
510(k) Number K253442
Device Name EarliPoint Assessment
Applicant
Earlitec Diagnostics
13895 Industrial Park Blvd. Suite 140
Plymouth,  MN  55441
Applicant Contact Ryan Bormann
Correspondent
RQM+
2790 Mosside Blvd.
Pittsburgh,  PA  15146
Correspondent Contact Amy Wolbeck
Regulation Number882.1491
Classification Product Code
QPF  
Date Received10/01/2025
Decision Date 03/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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