BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C

    K Number: K880584 · Decision May 31, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    111

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    Basic Information

    Device Name
    URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C
    K Number
    K880584
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1785
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Mach Diag. C/O Wichita State University
    Date Received
    February 10, 1988
    Decision Date
    May 31, 1988
    Product Code
    CDM
    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
    CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

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    Other Clearances by Mach Diag. C/O Wichita State University

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