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

    IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02

    K Number: K052793 · Decision Feb 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    41
    Applicant Total
    2
    Review Days
    127

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    Basic Information

    Device Name
    IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02
    K Number
    K052793
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pharmacia Diagnostics AB
    Date Received
    October 3, 2005
    Decision Date
    February 7, 2006
    Product Code
    MST
    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
    MST Antibodies, Gliadin

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    Other Clearances by Pharmacia Diagnostics AB

    K Number Device Name
    K051218 MODIFICATION TO: UNICAP SPECIFIC IGE