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

    SYSMEX POCH-100I

    K Number: K032677 · Decision Feb 11, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    31
    Review Days
    166

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    Basic Information

    Device Name
    SYSMEX POCH-100I
    K Number
    K032677
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sysmex America, Inc.
    Date Received
    August 29, 2003
    Decision Date
    February 11, 2004
    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 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. →