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

    ZEUS ELISA HSV GG-2 IGG TEST SYSTEM

    K Number: K103603 · Decision May 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    9
    Applicant Total
    135
    Review Days
    163

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    Basic Information

    Device Name
    ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
    K Number
    K103603
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zeus Scientific, Inc.
    Date Received
    December 8, 2010
    Decision Date
    May 20, 2011
    Product Code
    MYF
    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
    MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

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