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

    TOBRAMYCIN FLUORESCENT IMMUNOASSAY

    K Number: K813542 · Decision Jan 12, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    39
    Review Days
    22

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    Basic Information

    Device Name
    TOBRAMYCIN FLUORESCENT IMMUNOASSAY
    K Number
    K813542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Diagnostic Corp.
    Date Received
    December 21, 1981
    Decision Date
    January 12, 1982
    Product Code
    LCR
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LCR Fluorescent Immunoassay, Tobramycin

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