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

    VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)

    K Number: K060227 · Decision May 25, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    115

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    Basic Information

    Device Name
    VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
    K Number
    K060227
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vision Biosystems, Inc.
    Date Received
    January 30, 2006
    Decision Date
    May 25, 2006
    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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    Other Clearances by Vision Biosystems, Inc.

    K Number Device Name
    K062615 VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16