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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microbial Nucleic Acid Storage And Stabilization Device
510(k) Number K233324
Device Name Molecular Transport Media - MTM
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
Classification Product Code
QBD  
Date Received09/29/2023
Decision Date 06/17/2024
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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