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

    939UDX URINE PATHOLOGY SYSTEM

    K Number: K000373 · Decision Apr 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    14
    Applicant Total
    14
    Review Days
    70

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    Basic Information

    Device Name
    939UDX URINE PATHOLOGY SYSTEM
    K Number
    K000373
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intl. Remote Imaging Systems
    Date Received
    February 4, 2000
    Decision Date
    April 14, 2000
    Product Code
    LKM
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKM Counter, Urine Particle

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    Other Clearances by Intl. Remote Imaging Systems

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    K022774 IQ 200 SYSTEM
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    K953116 WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER
    K960054 900UDX URINE PATHOLOGY SYSTEM
    K954006 YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY
    K943463 THE YELLOW IRIS
    K934539 THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY
    K914256 YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU
    K893530 IRISTAIN FORMULA 2, PARTS 1 AND 2
    K874207 THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION
    Search all 14 clearances from Intl. Remote Imaging Systems →