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

    IMMUNE CELL FUNCTION ASSAY

    K Number: K013169 · Decision Apr 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    193

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    IMMUNE CELL FUNCTION ASSAY
    K Number
    K013169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cylex, Inc.
    Date Received
    September 21, 2001
    Decision Date
    April 2, 2002
    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.

    IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by Cylex, Inc.

    K Number Device Name
    K101911 IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY