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

    SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389

    K Number: K024162 · Decision Feb 19, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    28
    Applicant Total
    280
    Review Days
    64

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    Basic Information

    Device Name
    SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
    K Number
    K024162
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Helena Laboratories
    Date Received
    December 17, 2002
    Decision Date
    February 19, 2003
    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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