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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Antigen, Nuclear, Epstein-Barr Virus
510(k) Number K233605
Device Name ADVIA Centaur EBV-EBNA IgG
Applicant
Biokit, S.A.
Av. Can Montcau, 7
Lliçà D’Amunt, Barcelona,  ES 08186
Applicant Contact Dominique Monferrer
Correspondent
Biokit, S.A.
Av. Can Montcau, 7
Lliçà D’Amunt, Barcelona,  ES 08186
Correspondent Contact Dominique Monferrer
Regulation Number866.3235
Classification Product Code
LLM  
Subsequent Product Code
LSE  
Date Received11/09/2023
Decision Date 08/07/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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