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

    Her-2, ER, PR IHControls

    K Number: K220163 · Decision Aug 15, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    207

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    Basic Information

    Device Name
    Her-2, ER, PR IHControls
    K Number
    K220163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Cell Standards, Inc.
    Date Received
    January 20, 2022
    Decision Date
    August 15, 2022
    Product Code
    NJW
    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
    NJW Control Material, Her-2/Neu, Immunohistochemistry

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