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

    THE YELLOW IRIS URINALYSIS WORKSTATION

    K Number: K972141 · Decision Aug 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    45
    Applicant Total
    14
    Review Days
    80

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    THE YELLOW IRIS URINALYSIS WORKSTATION
    K Number
    K972141
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2900
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intl. Remote Imaging Systems
    Date Received
    June 6, 1997
    Decision Date
    August 25, 1997
    Product Code
    KQO
    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
    KQO Automated Urinalysis System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KQO), ordered by most recent decision date.

    URISCAN OPTIMA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CYBOW READER, MODELS 300 & 720

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Intl. Remote Imaging Systems

    K Number Device Name
    K022774 IQ 200 SYSTEM
    K000373 939UDX URINE PATHOLOGY SYSTEM
    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 →