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

    PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01

    K Number: K991945 · Decision Jul 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    113
    Applicant Total
    18
    Review Days
    49

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    Basic Information

    Device Name
    PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01
    K Number
    K991945
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pharmacia & Upjohn Co.
    Date Received
    June 9, 1999
    Decision Date
    July 28, 1999
    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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