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

    HERPES GROUP IGG

    K Number: K033059 · Decision Nov 26, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    37
    Applicant Total
    2
    Review Days
    58

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    Basic Information

    Device Name
    HERPES GROUP IGG
    K Number
    K033059
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trinity Biotech, Inc.
    Date Received
    September 29, 2003
    Decision Date
    November 26, 2003
    Product Code
    LGC
    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
    LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

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