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

    SIGMA SUDAN BLACK REAGENT 380-1

    K Number: K843684 · Decision Oct 31, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    231
    Review Days
    43

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    Basic Information

    Device Name
    SIGMA SUDAN BLACK REAGENT 380-1
    K Number
    K843684
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Sigma Chemical Co.
    Date Received
    September 18, 1984
    Decision Date
    October 31, 1984
    Product Code
    HZZ
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HZZ Sudan Black B

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