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

    PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION

    K Number: K923832 · Decision Nov 25, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    113
    Applicant Total
    2
    Review Days
    120

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    Basic Information

    Device Name
    PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION
    K Number
    K923832
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kabi Pharmacia, Inc.
    Date Received
    July 28, 1992
    Decision Date
    November 25, 1992
    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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