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

    UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA

    K Number: K973143 · Decision Sep 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    189
    Applicant Total
    8
    Review Days
    34

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    Basic Information

    Device Name
    UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA
    K Number
    K973143
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Universal Reagents, Inc.
    Date Received
    August 22, 1997
    Decision Date
    September 25, 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
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    K961929 FACTOR DEFICIENT PLASMA