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510(k) Data Aggregation
K Number
K090283Device Name
CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
Manufacturer
GENCHEM, INC.
Date Cleared
2009-06-05
(120 days)
Product Code
JIX
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
GENCHEM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SYNCHRON® CX Multi-Analyte Mixture Calibrators 1, 2, and 3 are intended to calibrate the Beckman® SYNCHRON CX® Systems for quantitative determination of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO2
Device Description
Not Found
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K Number
K040972Device Name
CALCIUM, AZO DYE REAGENT
Manufacturer
GENCHEM, INC.
Date Cleared
2004-12-27
(257 days)
Product Code
CJY
Regulation Number
862.1145Why did this record match?
Applicant Name (Manufacturer) :
GENCHEM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GenChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diseases associated with hypercalcemia and hypocalcemia.
Device Description
GenChem's Calcium reagent is a liquid composed of Arsenazo III and buffer for the quantitative determination of Calcium in serum, plasma and urine on the Beckman Synchron CX3® System.
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K Number
K040973Device Name
BUN REAGENT
Manufacturer
GENCHEM, INC.
Date Cleared
2004-12-27
(257 days)
Product Code
CDS
Regulation Number
862.1770Why did this record match?
Applicant Name (Manufacturer) :
GENCHEM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BUN Reagent is to be used for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of renal function and pre renal disease states, such as cardiac decompensation and others.
Device Description
The Device is a reagent containing sufficient Urease, surfactants and other ingredients necessary for optimum system operation on the Beckman Synchron CX3® Analyzer.
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K Number
K040974Device Name
GLUCOSE OXIDASE, GLUCOSE
Manufacturer
GENCHEM, INC.
Date Cleared
2004-12-27
(257 days)
Product Code
CGA
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
GENCHEM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GenChem Glucose Oxidase Reagent is for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diabetes, liver disease and certain endocrine disorders.
Device Description
The Device is a solution containing sufficient Glucose Oxidase, surfactants and other ingredients necessary for optimum system operation on the Beckman CX3® Analyzer.
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K Number
K040975Device Name
GENCHEM CO2 ACID REAGENT
Manufacturer
GENCHEM, INC.
Date Cleared
2004-12-27
(257 days)
Product Code
JFL
Regulation Number
862.1160Why did this record match?
Applicant Name (Manufacturer) :
GENCHEM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GenChem CO2 Acid Reagent when used in conjunction with the GenChem ISE Electrolyte Reference, GenChem Electrolyte Buffer, GenChem CO2 Alkaline Buffer, GenChem Wash Concentrate, and appropriate Calibrators or Calibration Standards is intended for the quantitative determination of Carbon Dioxide in serum and plasma on the Beckman CX3®. Carbon Dioxide results are used in the diagnosis and treatment of numerous and potentially serious disorders associated with changes in the body's acidbase balance.
Device Description
The Device is a solution containing 0.6 mol/L sulfuric acid, nonreactive surfactants and other ingredients necessary for optimum system operation.
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K Number
K040976Device Name
GENCHEM CREATININE REAGENT
Manufacturer
GENCHEM, INC.
Date Cleared
2004-12-27
(257 days)
Product Code
CGX
Regulation Number
862.1225Why did this record match?
Applicant Name (Manufacturer) :
GENCHEM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GenChem Creatinine Test Reagent System is intended for the quantitative determination of creatinine in serum, plasma and urine on the Beckman SYNCHRON CX3® System and as an aid in the diagnosis of renal impairment and diseases such as chronic glomerulonephritis, diabetic nephropathy, chronic interstitial nephritis and as an indicator of glomerular filtration rate.
Device Description
The Device is a Reagent containing alkaline picrate for the determination of creatinine for optimum system operation on the Beckman Synchron CX3® System.
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K Number
K040977Device Name
GENCHEM ELECTROLYTE BUFFER
Manufacturer
GENCHEM, INC.
Date Cleared
2004-12-27
(257 days)
Product Code
JGS, CEM, CGZ, JFL, JFP
Regulation Number
862.1665Why did this record match?
Applicant Name (Manufacturer) :
GENCHEM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GenChem ISE Electrolyte Buffer, when used in conjunction with the GenChem ISE Electrolyte Reference, GenChem CO2 Acid Reagent, GenChem CO2 Alkaline Buffer, GenChem Wash Concentrate, and appropriate Calibrators or Calibration Standards, is intended for the quantitative determination of sodium, potassium, chloride, and total CO2 in serum and plasma, and sodium, potassium and chloride in urine, and Reference will also determine calcium in serum, plasma and urine.
Sodium results are for the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by the destruction of the adrenal glands), dehvdration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium results are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels. Chloride results are used in the treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Carbon dioxide results are used in the diagnosis and treatment of numerous and potentially serious disorders associated with changes in the body's acid-base balance. Calcium results are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany (intermittent muscular contractions or spasm).
Device Description
Sodium, Potassium, Chloride, CO2 and Calcium are determined by the use of Ion Specific Electrodes, the conductivity of which is proportional to the concentration of electrolyte in the sample which is mixed with high ionic strength buffer using the ISE Solution as the reference.
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K Number
K040971Device Name
GENCHEM ISE ELECTROLYTE REFERENCE
Manufacturer
GENCHEM, INC.
Date Cleared
2004-12-22
(252 days)
Product Code
JGS, CEM, CGZ, JFL, JFP
Regulation Number
862.1665Why did this record match?
Applicant Name (Manufacturer) :
GENCHEM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GenChem ISE Electrolyte Reference, when used in conjunction with the GenChem ISE Electrolyte Buffer. GenChem CO2 Acid Reagent, GenChem CO2 Alkaline Buffer, GenChem Wash Concentrate, and appropriate Calibration Standards, is intended for the quantitative determination of sodium, potassium, chloride, and total CO2 in serum and plasma, and sodium, potassium and chloride in urine, and Reference will also determine calcium in serum, plasma and urine.
Sodium results are for the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by the destruction of the adrenal glands), dehvdration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium results are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels. Chloride results are used in the treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Carbon dioxide results are used in the diagnosis and treatment of numerous and potentially serious disorders associated with changes in the body's acid-base balance. Calcium results are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany (intermittent muscular contractions or spasm).
Device Description
Sodium, Potassium, Chloride, CO2 and Calcium are determined by the use of Ion Specific Electrodes, the conductivity of which is proportional to the concentration of electrolyte in the sample which is mixed with high ionic strength buffer using the ISE Solution as the reference.
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