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

    Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB

    K Number: K250814 · Decision May 8, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    417

    Basic Information

    Device Name
    Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB
    K Number
    K250814
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zeus Scientific
    Date Received
    March 17, 2025
    Decision Date
    May 8, 2026
    Product Code
    OBE
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OBE Anti-Ss-A 52 Autoantibodies

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