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

    FACTOR DEFICIENT PLASMAS - FACTOR IX (9)

    K Number: K972288 · Decision Jul 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    189
    Applicant Total
    8
    Review Days
    25

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    Basic Information

    Device Name
    FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
    K Number
    K972288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Universal Reagents, Inc.
    Date Received
    June 19, 1997
    Decision Date
    July 14, 1997
    Product Code
    GGP
    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
    GGP Test, Qualitative And Quantitative Factor Deficiency

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    Other Clearances by Universal Reagents, Inc.

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    K970607 UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
    K970593 UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
    K964270 UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
    K964459 UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
    K961929 FACTOR DEFICIENT PLASMA