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

    LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX

    K Number: K260770 · Decision Jun 4, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    0
    Applicant Total
    71
    Review Days
    87

    Basic Information

    Device Name
    LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
    K Number
    K260770
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3172
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DiaSorin, Inc.
    Date Received
    March 9, 2026
    Decision Date
    June 4, 2026
    Product Code
    LOM
    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
    LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

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