BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120

    K Number: K963055 · Decision May 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    12
    Applicant Total
    10
    Review Days
    269

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    Basic Information

    Device Name
    IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
    K Number
    K963055
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3375
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Genbio
    Date Received
    August 6, 1996
    Decision Date
    May 2, 1997
    Product Code
    LJZ
    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
    LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

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