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

    Biolinq Shine Autonomous Time-in-Range Microsensor

    K Number: DEN240080 · Decision Sep 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    270

    Basic Information

    Device Name
    Biolinq Shine Autonomous Time-in-Range Microsensor
    K Number
    DEN240080
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    862.1359
    Medical Specialty
    Clinical Chemistry
    Decision
    Unknown
    Applicant
    Biolinq Incorporated
    Date Received
    December 27, 2024
    Decision Date
    September 23, 2025
    Product Code
    SFU
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SFU Glucose Range Monitoring System