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

    AMIDO BLACK CONCENTRATE

    K Number: K771720 · Decision Nov 3, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    28
    Applicant Total
    231
    Review Days
    51

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    Basic Information

    Device Name
    AMIDO BLACK CONCENTRATE
    K Number
    K771720
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1630
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sigma Chemical Co.
    Date Received
    September 13, 1977
    Decision Date
    November 3, 1977
    Product Code
    CEF
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CEF Electrophoretic, Protein Fractionation

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