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

    IMMUNOENZYME TEST SYS-DETECT-IGM ANTI

    K Number: K832900 · Decision Nov 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    17
    Applicant Total
    8
    Review Days
    77

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    Basic Information

    Device Name
    IMMUNOENZYME TEST SYS-DETECT-IGM ANTI
    K Number
    K832900
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Bionetic Laboratory Products
    Date Received
    August 29, 1983
    Decision Date
    November 14, 1983
    Product Code
    GLZ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GLZ Antigens, If, Toxoplasma Gondii

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