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

    ANTI-TOXOPLASMA GONDII KIT

    K Number: K842664 · Decision Aug 28, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    17
    Applicant Total
    32
    Review Days
    49

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    Basic Information

    Device Name
    ANTI-TOXOPLASMA GONDII KIT
    K Number
    K842664
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Amico Lab, Inc.
    Date Received
    July 10, 1984
    Decision Date
    August 28, 1984
    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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