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

    HEMOSIL FACTOR II DEFICIENT PLASMA

    K Number: K050661 · Decision May 2, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    78
    Applicant Total
    321
    Review Days
    48

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    Basic Information

    Device Name
    HEMOSIL FACTOR II DEFICIENT PLASMA
    K Number
    K050661
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    March 15, 2005
    Decision Date
    May 2, 2005
    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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