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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 K213882
Device Name EarliPoint System
Applicant
EarliTec Diagnostics, Inc.
755 Commerce Drive, Suite 700
Decatur,  GA  30030
Applicant Contact Thomas Ressemann
Correspondent
Libra Medical, Inc.
8401 73rd Ave N, Suite 63
Brooklyn Park,  MN  55428
Correspondent Contact Sew-Wah Tay
Regulation Number882.1491
Classification Product Code
QPF  
Date Received12/13/2021
Decision Date 06/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT03469986
NCT04860986
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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