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

    NETILMICIN FLUORESCENT IMMUNOASSAY

    K Number: K822941 · Decision Oct 26, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    39
    Review Days
    22

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    Basic Information

    Device Name
    NETILMICIN FLUORESCENT IMMUNOASSAY
    K Number
    K822941
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Diagnostic Corp.
    Date Received
    October 4, 1982
    Decision Date
    October 26, 1982
    Product Code
    LCE
    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
    LCE Radioimmunoassay, Netilmicin (I-125)

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