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

    TOXO IPA KIT IAN INDIRECT FLUORESCENT

    K Number: K832069 · Decision Sep 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    8
    Review Days
    91

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    Basic Information

    Device Name
    TOXO IPA KIT IAN INDIRECT FLUORESCENT
    K Number
    K832069
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Bionetic Laboratory Products
    Date Received
    June 27, 1983
    Decision Date
    September 26, 1983
    Product Code
    LJK
    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
    LJK Antisera, If, Toxoplasma Gondii

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