BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DAKOCYTOMATION ER/PR PHARMDX KIT

    K Number: K042884 · Decision Feb 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    119

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    Basic Information

    Device Name
    DAKOCYTOMATION ER/PR PHARMDX KIT
    K Number
    K042884
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dakocytomation California, Inc.
    Date Received
    October 19, 2004
    Decision Date
    February 15, 2005
    Product Code
    MXZ
    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
    MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor

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    Other Clearances by Dakocytomation California, Inc.

    K Number Device Name
    K060423 CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES