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

    GENTAMICIN TEST PACK-ACA

    K Number: K831210 · Decision May 25, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    18
    Applicant Total
    253
    Review Days
    41

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    Basic Information

    Device Name
    GENTAMICIN TEST PACK-ACA
    K Number
    K831210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    April 14, 1983
    Decision Date
    May 25, 1983
    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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