EarliPoint System

Pediatric Autism Spectrum Disorder Diagnosis Aid

EarliTec Diagnostics, Inc.

The following data is part of a premarket notification filed by Earlitec Diagnostics, Inc. with the FDA for Earlipoint System.

Pre-market Notification Details

Device IDK213882
510k NumberK213882
Device Name:EarliPoint System
ClassificationPediatric Autism Spectrum Disorder Diagnosis Aid
Applicant EarliTec Diagnostics, Inc. 755 Commerce Drive, Suite 700 Decatur,  GA  30030
ContactThomas Ressemann
CorrespondentSew-Wah Tay
Libra Medical, Inc. 8401 73rd Ave N, Suite 63 Brooklyn Park,  MN  55428
Product CodeQPF  
CFR Regulation Number882.1491 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-13
Decision Date2022-06-08

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