BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

    K Number: K230675 · Decision Jun 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    468

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    Basic Information

    Device Name
    VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
    K Number
    K230675
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1650
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Specific Diagnostics, LLC
    Date Received
    March 10, 2023
    Decision Date
    June 20, 2024
    Product Code
    SAN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples

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