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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 K240279
Device Name VIDAS TBI (GFAP, UCH-L1)
Applicant
bioMerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact Chris Goodpaster
Correspondent
bioMerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact Chris Goodpaster
Regulation Number866.5830
Classification Product Code
QAT  
Date Received02/01/2024
Decision Date 05/01/2024
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
Predetermined Change
Control Plan Authorized		 No
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