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

    YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY

    K Number: K954006 · Decision Mar 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    14
    Review Days
    200

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    Basic Information

    Device Name
    YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY
    K Number
    K954006
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intl. Remote Imaging Systems
    Date Received
    August 25, 1995
    Decision Date
    March 12, 1996
    Product Code
    GKL
    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
    GKL Counter, Cell, Automated (Particle Counter)

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    Other Clearances by Intl. Remote Imaging Systems

    K Number Device Name
    K022774 IQ 200 SYSTEM
    K000373 939UDX URINE PATHOLOGY SYSTEM
    K972141 THE YELLOW IRIS URINALYSIS WORKSTATION
    K953116 WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER
    K960054 900UDX URINE PATHOLOGY SYSTEM
    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 →