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

    QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM

    K Number: K904603 · Decision Jan 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    115
    Applicant Total
    8
    Review Days
    107

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    Basic Information

    Device Name
    QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM
    K Number
    K904603
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1635
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Quantitative Medicine, Inc.
    Date Received
    October 10, 1990
    Decision Date
    January 25, 1991
    Product Code
    CEK
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CEK Biuret (Colorimetric), Total Protein

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