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

    VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)

    K Number: K984567 · Decision Aug 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    232

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    Basic Information

    Device Name
    VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
    K Number
    K984567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ventana, Inc.
    Date Received
    December 23, 1998
    Decision Date
    August 12, 1999
    Product Code
    MYA
    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
    MYA Immunohistochemistry Antibody Assay, Estrogen Receptor

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