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

    AMINOGLYCOSIDE CONTROLS

    K Number: K761156 · Decision Dec 9, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    7
    Applicant Total
    24
    Review Days
    10

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    Basic Information

    Device Name
    AMINOGLYCOSIDE CONTROLS
    K Number
    K761156
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5530
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Supelco, Inc.
    Date Received
    November 29, 1976
    Decision Date
    December 9, 1976
    Product Code
    DAS
    Advisory Committee
    Immunology
    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
    DAS Igg (Fc Fragment Specific), Antigen, Antiserum, Control

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