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

    KENAMYCIN FLUORESCENT IMMUNOASSAY FIA

    K Number: K823062 · Decision Nov 10, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    39
    Review Days
    23

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    Basic Information

    Device Name
    KENAMYCIN FLUORESCENT IMMUNOASSAY FIA
    K Number
    K823062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3520
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Diagnostic Corp.
    Date Received
    October 18, 1982
    Decision Date
    November 10, 1982
    Product Code
    KJI
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KJI Radioimmunoassay, Kanamycin

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