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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 K243891
Device Name EarliPoint System
Applicant
Earlitec Diagnostics
755 Commerce Dr., Suite 700
Atlanta,  GA  30030
Applicant Contact Ryan Bormann
Correspondent
RQM+
2790 Mosside Blvd.
Pittsburgh,  PA  15146
Correspondent Contact Amy Wolbeck
Regulation Number882.1491
Classification Product Code
QPF  
Date Received12/18/2024
Decision Date 03/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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