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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brain Trauma Assessment Test
510(k) Number K223602
Device Name Traumatic brain injury (TBI) test
Applicant
Abbott Laboratories
100 Abbott Park Road
Abbott Park,  IL  60064
Applicant Contact Lisa Kelly
Correspondent
Abbott Laboratories
100 Abbott Park Road
Abbott Park,  IL  60064
Correspondent Contact Lisa Kelly
Regulation Number866.5830
Classification Product Code
QAT  
Date Received12/02/2022
Decision Date 03/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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