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

    GILL HEMATOXYLIN STAIN

    K Number: K842741 · Decision Aug 15, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    13
    Applicant Total
    50
    Review Days
    33

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    Basic Information

    Device Name
    GILL HEMATOXYLIN STAIN
    K Number
    K842741
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    E K Ind., Inc.
    Date Received
    July 13, 1984
    Decision Date
    August 15, 1984
    Product Code
    HYJ
    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
    HYJ Hematoxylin

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