BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    IVD CAPSULE PSP; abioSCOPE

    K Number: K240041 · Decision Sep 25, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    264

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    Basic Information

    Device Name
    IVD CAPSULE PSP; abioSCOPE
    K Number
    K240041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3215
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abionic SA
    Date Received
    January 5, 2024
    Decision Date
    September 25, 2024
    Product Code
    SCX
    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
    SCX Immunoassay For Host Biomarkers Of Sepsis