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

    KALLESTAD ANTISERA TO TOBRAMYCIN

    K Number: K812415 · Decision Sep 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    92
    Review Days
    9

    Basic Information

    Device Name
    KALLESTAD ANTISERA TO TOBRAMYCIN
    K Number
    K812415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    KALLESTAD LABORATORIES, INC.
    Date Received
    August 31, 1981
    Decision Date
    September 9, 1981
    Product Code
    KLB
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KLB Radioimmunoassay, Tobramycin

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