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

    MACRO-VUE CARD TEST, AMIKACIN

    K Number: K821771 · Decision Jun 25, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    19
    Applicant Total
    632
    Review Days
    9

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    Basic Information

    Device Name
    MACRO-VUE CARD TEST, AMIKACIN
    K Number
    K821771
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3035
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    June 16, 1982
    Decision Date
    June 25, 1982
    Product Code
    KLQ
    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
    KLQ Radioimmunoassay, Amikacin

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