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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 K232669
Device Name TBI
Applicant
Abbott Laboratories
100 Abbott Park Rd.
Dept.09aa, Bldg. Cp1
Abbott Park,  IL  60064
Applicant Contact Lisa Kelly
Correspondent
Abbott Laboratories
100 Abbott Park Rd.
Dept.09aa, Bldg. Cp1
Abbott Park,  IL  60064
Correspondent Contact Lisa Kelly
Regulation Number866.5830
Classification Product Code
QAT  
Date Received09/01/2023
Decision Date 09/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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