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

    LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system

    K Number: K251875 · Decision Oct 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    131

    Basic Information

    Device Name
    LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
    K Number
    K251875
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1650
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Affinity Biosensors, LLC
    Date Received
    June 18, 2025
    Decision Date
    October 27, 2025
    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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    Other Clearances by Affinity Biosensors, LLC

    K Number Device Name
    K241324 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system