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

    Access Syphilis

    K Number: K241427 · Decision Sep 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    34
    Applicant Total
    270
    Review Days
    109

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    Basic Information

    Device Name
    Access Syphilis
    K Number
    K241427
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    May 20, 2024
    Decision Date
    September 6, 2024
    Product Code
    LIP
    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
    LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

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