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510(k) Data Aggregation
K Number
K183375Device Name
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
Manufacturer
Horiba, Ltd
Date Cleared
2019-02-12
(68 days)
Product Code
JJE, CEM, CFR, CGZ, JGS
Regulation Number
862.2160Why did this record match?
Applicant Name (Manufacturer) :
Horiba, Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Yumizen C1200 Glucose HK reagent is intended for the quantitative in vitro diagnostic determination of gluose in human serum, plasma, and urine using a glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
The sodium electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The sodium electrode is used to quantify the concentrations of sodium ions in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The potassium electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The potassium electrode is used to quantify the concentrations of potassium ions in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels.
The chloride electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The chloride electrode is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The chloride electrode is used to quantify the concentrations of chloride ions in serum, plasma, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The Yumizen C1200 is an automatic chemistry analyzer that measures in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. Applications include colorimetric and ion selective electrode. This analyzer is intended for professional use in a laboratory environment only. Tests performed using this analyzer are intended for in vitro diagnostic use.
Device Description
The Yumizen C1200 is an automatic chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. Applications include colorimetric and ion selective electrode. This analyzer is intended for professional use in a laboratory environment only. Tests performed using this analyzer are intended for in vitro diagnostic use. The system includes the Yumizen C1200 Glucose HK reagent, Sodium Electrode, Potassium Electrode, and Chloride Electrode. The analyzer uses photometric measurement and ion selective electrodes.
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