BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    CAPTIAM SYPHILIS-G ASSAY

    K Number: K014233 · Decision Jan 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    34
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    CAPTIAM SYPHILIS-G ASSAY
    K Number
    K014233
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trinity Biotech, Plc
    Date Received
    December 26, 2001
    Decision Date
    January 24, 2002
    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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