LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K021241
    Device Name
    SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
    Manufacturer
    SYSMEX CORPORATION OF AMERICA
    Date Cleared
    2002-06-25

    (67 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYSMEX CORPORATION OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sysmex® XT-Series is intended for in vitro diagnostic use in the clinical laboratory as a multi-parameter hematology analyzer.
    Device Description
    The XT-Series is an automated hematology analyzer which consists of four principle units: (1) Main Unit which aspirates, dilutes, mixes, and analyzes whole blood samples; (2) Sampler Unit which supplies samples to the Main Unit automatically: (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system: (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit.
    Ask a Question
    K Number
    K020496
    Device Name
    HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY
    Manufacturer
    SYSMEX CORPORATION OF AMERICA
    Date Cleared
    2002-04-12

    (57 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYSMEX CORPORATION OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HPC (hematopoietic progenitor cell) parameter of the IMI Channel on the Sysmex® SE-9500 and XE-2100 for in Vitro Diagnostics is used as a screen for the optimal presence of hematopoietic progenitor cells in peripheral blood and cord blood samples.
    Device Description
    The SE-9500 and XE-2100 have an immature myeloid information (IMI) channel, which identifies and enumerates immature cells in addition to the traditionally reported parameters of an automated cell differential. (Note: Special software/hardware is required to obtain results described.)
    Ask a Question
    K Number
    K001683
    Device Name
    SYSMEX R-500
    Manufacturer
    SYSMEX CORPORATION OF AMERICA
    Date Cleared
    2000-08-21

    (81 days)

    Product Code
    GKL
    Regulation Number
    864.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYSMEX CORPORATION OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1