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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Propagating Transport
510(k) Number K232454
Device Name Viral Transport Media (VTM)
Applicant
Alb Luz
Rua Um, 437
Valinhos,  BR 13273-200
Applicant Contact Ana Luiza Bueno Luz
Correspondent
Pr Servicos Regulatorios Administrativos Ltda
Rua Alice Alem Saadi, 855/2402
Ribeirao Preto,  BR 14096-570
Correspondent Contact Graziela Brum
Regulation Number866.2390
Classification Product Code
JSM  
Subsequent Product Code
LIO  
Date Received08/14/2023
Decision Date 05/03/2024
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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