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

    FebriDx Bacterial / Non-bacterial Point of Care Assay

    K Number: K230917 · Decision Jun 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    FebriDx Bacterial / Non-bacterial Point of Care Assay
    K Number
    K230917
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3230
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lumos Diagnostics, Inc.
    Date Received
    April 3, 2023
    Decision Date
    June 30, 2023
    Product Code
    QXA
    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
    QXA Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

    Similar 510(k) Clearances

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

    FebriDx Bacterial/Non-bacterial Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Lumos Diagnostics, Inc.

    K Number Device Name
    K260787 FebriDx Bacterial/Non-bacterial Assay