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

    IQ 200 SYSTEM

    K Number: K022774 · Decision Oct 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    14
    Applicant Total
    14
    Review Days
    61

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    Basic Information

    Device Name
    IQ 200 SYSTEM
    K Number
    K022774
    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
    August 21, 2002
    Decision Date
    October 21, 2002
    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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    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
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