BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GENTAMICIN-50MG/ML

    K Number: K861869 · Decision May 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    366
    Applicant Total
    47
    Review Days
    14

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    Basic Information

    Device Name
    GENTAMICIN-50MG/ML
    K Number
    K861869
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hazleton Research Products, Inc.
    Date Received
    May 15, 1986
    Decision Date
    May 29, 1986
    Product Code
    KIT
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KIT Media And Components, Synthetic Cell And Tissue Culture

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