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510(k) Data Aggregation

    K Number
    K983562
    Device Name
    MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700
    Date Cleared
    1998-11-03

    (21 days)

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

    CDC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MD 700 is a multi-parameter, automated hematology analyzer used to perform in vitro analysis of human peripheral blood in clinical laboratories. The MD 700 reports on the following parameters: White Blood Cells (Leukocytes) WBC Red Blood Cells (Erythrocytes) RBC Hemoglobin Concentration Hgb Hematocrit (relative volume of erythrocytes) Hct Mean Corpuscular (erythrocyte) Volume MCV Mean Corpuscular (erythrocyte) Hemoglobin MCH Mean Corpuscular (erythrocyte) Hemoglobin Concentration MCHC Red Blood Cell (erythrocyte volume) Distribution Width RDW Platelet or Thrombocyte Count Plt Granulocyte (number) GR# Granulocyte (percent of WBC) GR% Lymphocyte (number) LY# Lymphocyte (percent of WBC) LY% Monocyte (number) MO# Monocyte (percent of WBC) MO%
    Device Description
    The MD 700 is a quantitative analyzer of peripheral human blood for in vitro diagnostic use in clinical laboratories. It performs an automated complete blood count (CBC) and a leukocyte differential on peripheral human blood. A sample volume of 20 uL of whole blood is required. The instrument provides a printed report on 15 parameters. The MD 700 consists of five components: (1) A blood analysis instrument, (2) A reagent dispensing unit and four reagents, (3) Calibration and control reagents, (4) Probeclenz™, a cleaning liquid, and (5) A standard, off-the-shelf high resolution printer. The MD 700 analyzes human peripheral blood by passing electronic waves through precisely measured dilutions of the blood, and analyzing the results using software which relies upon a patented mathematical algorithm to determine the count and percent of each parameter reported.
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    K Number
    K981568
    Device Name
    MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800
    Date Cleared
    1998-08-21

    (112 days)

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

    CDC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MD 800 is a multi-parameter, automated hematology analyzer used to perform in vitro diagnosis of peripheral human blood in clinical laboratories. The MD 800 reports on the following parameters: White Blood Cells (Leukocytes) WBC Red Blood Cells (Erythrocytes) RBC Hemoglobin Concentration Hgb Hematocrit (relative volume of erythrocytes) Hct Mean Corpuscular (erythrocyte) Volume MCV Mean Corpuscular (erythrocyte) Hemoglobin MCH Mean Corpuscular (erythrocyte) Hemoglobin Concentration MCHC Red Blood Cell (erythrocyte volume) Distribution Width RDW Platelet or Thrombocyte Count Plt Mean Platelet (thrombocyte) Volume MPV Lymphocyte (number) LY# Lymphocyte (percent of WBC) LY% Monocyte (number) MO# Monocyte (percent of WBC) MO% Basophil (number) BA# Basophil (percent of WBC) BA % Neutrophil (number) NE# Neutrophil (percent of WBC) NE% Eosinophil (number) EO# Eosinophil (percent of WBC) EO %
    Device Description
    The MD 800 is a quantitative analyzer of peripheral human blood for in vitro diagnostic use in clinical laboratories. It performs an automated complete blood count (CBC) and a leukocyte differential on peripheral human blood. A sample volume of 20 uL of whole blood is required. The instrument provides a printed report on 20 parameters. The MD 800 consists of five components: (1) A blood analysis instrument, (2) A reagent dispensing unit and four reagents, (3) Calibration and control reagents, (4) Probeclenz™, a cleaning liquid, and (5) A standard, off-the-shelf high resolution printer. The instrument uses precise, motorized syringes, electronically controlled valves, cuvettes, transducer chambers, connective tubing and wiring, a communications panel, and a computer and related software program to analyze the blood sample.
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