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

    QUANTIMUNE GENTAMICIN RIA GENTAMICIN

    K Number: K791770 · Decision Oct 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    18
    Applicant Total
    319
    Review Days
    40

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    Basic Information

    Device Name
    QUANTIMUNE GENTAMICIN RIA GENTAMICIN
    K Number
    K791770
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Bio-Rad
    Date Received
    September 7, 1979
    Decision Date
    October 17, 1979
    Product Code
    DJB
    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
    DJB Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.

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