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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 K230337
Device Name EarliPoint
Applicant
EarliTec Diagnostics, Inc
755 Commerce Drive, Suite 700
Decatur,  GA  30030
Applicant Contact Ryan Bormann
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 Received02/07/2023
Decision Date 06/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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