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

    TESTCORP CRP

    K Number: K831362 · Decision May 27, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    69
    Applicant Total
    13
    Review Days
    31

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    Basic Information

    Device Name
    TESTCORP CRP
    K Number
    K831362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Catheter Technology Corp.
    Date Received
    April 26, 1983
    Decision Date
    May 27, 1983
    Product Code
    DCN
    Advisory Committee
    Immunology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DCN System, Test, C-Reactive Protein

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