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

    QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

    K Number: K023335 · Decision Jun 18, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    254

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    Basic Information

    Device Name
    QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
    K Number
    K023335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qc Sciences, LLC
    Date Received
    October 7, 2002
    Decision Date
    June 18, 2003
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NJW), ordered by most recent decision date.

    Her-2, ER, PR IHControls

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