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

    IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY

    K Number: K101911 · Decision Oct 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    101

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    Basic Information

    Device Name
    IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY
    K Number
    K101911
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cylex, Inc.
    Date Received
    July 9, 2010
    Decision Date
    October 18, 2010
    Product Code
    NID
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NID Assay, Proliferation, In Vitro, T Lymphocyte

    Similar 510(k) Clearances

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

    IMMUNE CELL FUNCTION ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology
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    Other Clearances by Cylex, Inc.

    K Number Device Name
    K013169 IMMUNE CELL FUNCTION ASSAY