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510(k) Data Aggregation
K Number
K983562Device Name
MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700
Manufacturer
Date Cleared
1998-11-03
(21 days)
Product Code
Regulation Number
864.5220Why 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
K981568Device Name
MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800
Manufacturer
Date Cleared
1998-08-21
(112 days)
Product Code
Regulation Number
864.5220Why 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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