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

    MRI GENTAMICIN RIA KIT

    K Number: K812394 · Decision Sep 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    18
    Applicant Total
    8
    Review Days
    19

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    Basic Information

    Device Name
    MRI GENTAMICIN RIA KIT
    K Number
    K812394
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Microanalytic Research, Inc.
    Date Received
    August 20, 1981
    Decision Date
    September 8, 1981
    Product Code
    DJB
    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
    DJB Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.

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