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

    SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER

    K Number: K083002 · Decision Feb 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    14
    Applicant Total
    31
    Review Days
    118

    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
    SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
    K Number
    K083002
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.5200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sysmex America, Inc.
    Date Received
    October 8, 2008
    Decision Date
    February 3, 2009
    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

    Similar 510(k) Clearances

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

    iQ200 Series

    FDA 510(k)
    FDA Class 2 ·Hematology

    AUTION EYE AI-4510 Urine Particle Analysis System

    FDA 510(k)
    FDA Class 2 ·Hematology

    iQ200 System, iChemVELOCITY Automated Urine Chemistry System

    FDA 510(k)
    FDA Class 2 ·Hematology

    cobas u 701 microscopy analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    Sysmex UF-5000 Fully Automated Urine Particle Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by Sysmex America, Inc.

    K Number Device Name
    K253212 XR-Series (XR-10, XR-20) Automated Hematology Analyzers
    K250943 Sysmex XR-Series (XR-10) Automated Hematology Analyzer
    K251371 Sysmex XR-Series (XR-20) Automated Hematology Analyzer
    K250965 Automated Blood Coagulation Analyzer CN-Series (CN-6000)
    K230887 Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
    K210346 Sysmex XW-100 Automated Hematology Analyzer
    K182389 Sysmex XN-L Automated Hematology Analyzer
    K182062 Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
    K171883 Sysmex UF-5000 Fully Automated Urine Particle Analyzer
    K172604 XW-100 Automated Hematology Analyzer for CLIA Waived Use
    Search all 31 clearances from Sysmex America, Inc. →