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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
510(k) Number K230675
Device Name VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
Applicant
Specific Diagnostics, LLC
130 Baytech Dr.
San Jose,  CA  95134
Applicant Contact Jolyn Tenllado
Correspondent
MDC Associates
180 Cabot St.,
Beverly,  MA  01915
Correspondent Contact Katie Hahnemann
Classification Product Code
SAN  
Subsequent Product Code
LON  
Date Received03/10/2023
Decision Date 06/20/2024
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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