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

    DIAPHARMA FACTOR X KIT

    K Number: K040362 · Decision Jul 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    78
    Applicant Total
    1
    Review Days
    150

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    Basic Information

    Device Name
    DIAPHARMA FACTOR X KIT
    K Number
    K040362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diapharma Group, Inc.
    Date Received
    February 13, 2004
    Decision Date
    July 12, 2004
    Product Code
    GJT
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GJT Plasma, Coagulation Factor Deficient

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