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

    INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT

    K Number: K120169 · Decision Aug 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    28
    Applicant Total
    2
    Review Days
    218

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    Basic Information

    Device Name
    INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
    K Number
    K120169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Grifols USA, LLC
    Date Received
    January 19, 2012
    Decision Date
    August 24, 2012
    Product Code
    CFF
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)

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