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

    PBC Separator with Selux AST System

    K Number: K244044 · Decision Mar 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    88

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    Basic Information

    Device Name
    PBC Separator with Selux AST System
    K Number
    K244044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1650
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Selux Diagnostics, Inc.
    Date Received
    December 30, 2024
    Decision Date
    March 28, 2025
    Product Code
    QZX
    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
    QZX Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QZX), ordered by most recent decision date.

    PBC Separator with Selux AST System

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    Other Clearances by Selux Diagnostics, Inc.

    K Number Device Name
    K223493 PBC Separator with Selux AST System
    K211748 Selux AST System; Model AST Gen 1.0
    K211759 Selux AST System; Model AST Gen 1.0