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

    EarliPoint Assessment

    K Number: K253442 · Decision Mar 5, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    155

    Basic Information

    Device Name
    EarliPoint Assessment
    K Number
    K253442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1491
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Earlitec Diagnostics
    Date Received
    October 1, 2025
    Decision Date
    March 5, 2026
    Product Code
    QPF
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QPF Pediatric Autism Spectrum Disorder Diagnosis Aid

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