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    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    ASTar BC G- Kit

    K Number: K253573 · Decision Apr 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    149

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    Basic Information

    Device Name
    ASTar BC G- Kit
    K Number
    K253573
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1650
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Q-Linea AB
    Date Received
    November 17, 2025
    Decision Date
    April 15, 2026
    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 Q-Linea AB

    K Number Device Name
    K221688 ASTar BC G- Kit and ASTar Instrument