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510(k) Data Aggregation

    K Number
    K090283
    Device 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
    862.1150
    Why 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
    K040972
    Device Name
    CALCIUM, AZO DYE REAGENT
    Manufacturer
    GENCHEM, INC.
    Date Cleared
    2004-12-27

    (257 days)

    Product Code
    CJY
    Regulation Number
    862.1145
    Why 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
    K040973
    Device Name
    BUN REAGENT
    Manufacturer
    GENCHEM, INC.
    Date Cleared
    2004-12-27

    (257 days)

    Product Code
    CDS
    Regulation Number
    862.1770
    Why 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
    K040974
    Device Name
    GLUCOSE OXIDASE, GLUCOSE
    Manufacturer
    GENCHEM, INC.
    Date Cleared
    2004-12-27

    (257 days)

    Product Code
    CGA
    Regulation Number
    862.1345
    Why 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
    K040975
    Device Name
    GENCHEM CO2 ACID REAGENT
    Manufacturer
    GENCHEM, INC.
    Date Cleared
    2004-12-27

    (257 days)

    Product Code
    JFL
    Regulation Number
    862.1160
    Why 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
    K040976
    Device Name
    GENCHEM CREATININE REAGENT
    Manufacturer
    GENCHEM, INC.
    Date Cleared
    2004-12-27

    (257 days)

    Product Code
    CGX
    Regulation Number
    862.1225
    Why 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
    K040977
    Device Name
    GENCHEM ELECTROLYTE BUFFER
    Manufacturer
    GENCHEM, INC.
    Date Cleared
    2004-12-27

    (257 days)

    Product Code
    JGS, CEM, CGZ, JFL, JFP
    Regulation Number
    862.1665
    Why 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
    K040971
    Device Name
    GENCHEM ISE ELECTROLYTE REFERENCE
    Manufacturer
    GENCHEM, INC.
    Date Cleared
    2004-12-22

    (252 days)

    Product Code
    JGS, CEM, CGZ, JFL, JFP
    Regulation Number
    862.1665
    Why 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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