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

    MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM

    K Number: K934594 · Decision Apr 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    113
    Applicant Total
    125
    Review Days
    209

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    Basic Information

    Device Name
    MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
    K Number
    K934594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    September 24, 1993
    Decision Date
    April 21, 1994
    Product Code
    DGC
    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
    DGC Ige, Antigen, Antiserum, Control

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