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

    ORTHO FACTOR XI DEFICIENT PLASMA

    K Number: K883691 · Decision Nov 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    78
    Applicant Total
    126
    Review Days
    64

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    Basic Information

    Device Name
    ORTHO FACTOR XI DEFICIENT PLASMA
    K Number
    K883691
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostic Systems, Inc.
    Date Received
    August 29, 1988
    Decision Date
    November 1, 1988
    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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