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510(k) Data Aggregation

    K Number
    K090013
    Device Name
    CHEMPAQ XBC ANALYZER
    Manufacturer
    Date Cleared
    2009-04-21

    (109 days)

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

    CHEMPAQ A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Chempaq XBC Analyzer is an in vitro diagnostic method intended for the quantitative determination of the concentration of white blood cells ("WBC"); granulocytes ("GRN"); lymphocytes ("LYM"); monocytes ("MON"); and total hemoglobin ("HGB") in whole-blood samples (finger stick or venous sample). The Chempaq XBC Analyzer is indicated for use in: clinical laboratories, and for point-of-care hematology determinations in doctors' offices or by healthcare professionals in hospital settings to identify and classify one or more of the formed elements of blood.
    Device Description
    Automated differential cell counter
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    K Number
    K050758
    Device Name
    CHEMPAQ XBC ANALYZER
    Manufacturer
    Date Cleared
    2005-12-22

    (274 days)

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

    CHEMPAQ A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Chempaq XBC Analyzer is an in vitro diagnostic method intended for the quantitative determination of the concentration of white blood cells ("WBC"); granulocytes ("GRN"); lymphocytes ("LYM"); monocytes ("MON"); and total hemoglobin ("Hb") in whole-blood samples (finger stick or venous sample). The Chempaq XBC Analyzer is indicated for use in: clinical laboratories, and for point-of-care hematology determinations in doctors' offices or by healthcare professionals in hospital settings to identify and classify one or more of the formed elements of blood.
    Device Description
    The Chempaq XBC Analyzer consists of a single use cartridge, called the PAQ (Particle Analyzer and Quantifier), and a stationary Reader with a docking station, called a Cradle. The PAQ is connected to the Cradle by a simple push fit. The PAQ includes all required reagents and will, when connected to the Cradle, perform all sample manipulations required for the analysis. The sample manipulation is facilitated by electrical and pneumatic connections between the PAQ and the Cradle. The user is not required to add any reagent to the Reader. The test procedure is very simple, as the user is only required to apply blood to the PAQ and place it into the Cradle. The rest of the test is carried out automatically within 3 minutes. No manipulation of reagents or other materials by the user is required.
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