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510(k) Data Aggregation

    K Number
    K013152
    Device Name
    ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
    Manufacturer
    ELAN HOLDINGS, INC.
    Date Cleared
    2001-11-09

    (50 days)

    Product Code
    LBS, JIS
    Regulation Number
    862.1475
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC PAK Direct HDL Reagent Kit, the ATAC Direct HDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of HDL-cholesterol in serum and plasma. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the risk of developing cardiovascular disease. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
    Device Description
    The ATAC PAK Direct HDL Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase and cholesterol oxidase on HDL-cholesterol while rendering other sources of cholesterol inactive. The resulting increase in absorbance at approximately 600 nm is proportional to the HDL-cholesterol concentration in the sample.
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    K Number
    K012474
    Device Name
    ATAC PAK CPK REAGENT KIT
    Manufacturer
    ELAN HOLDINGS, INC.
    Date Cleared
    2001-10-03

    (62 days)

    Product Code
    CGS
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC PAK CPK Reagent Kit and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of creatine kinase in serum and plasma. Creatine Kinase measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
    Device Description
    The ATAC PAK CPK Reagent Kit and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of creatine kinase in serum and plasma. Creatine kinase results are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The ATAC PAK CPK Reagent determines creatine kinase activity in the sample by measuring the rate of increase in absorbance at approximately 340 nm, which is proportional to the rate of progression of NAD to NADH.
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    K Number
    K010488
    Device Name
    ATAC PAK AST REAGENT KIT
    Manufacturer
    ELAN HOLDINGS, INC.
    Date Cleared
    2001-04-09

    (48 days)

    Product Code
    CIT
    Regulation Number
    862.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000958
    Device Name
    ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
    Manufacturer
    ELAN HOLDINGS, INC.
    Date Cleared
    2000-05-24

    (61 days)

    Product Code
    CDQ
    Regulation Number
    862.1770
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000900
    Device Name
    ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
    Manufacturer
    ELAN HOLDINGS, INC.
    Date Cleared
    2000-05-02

    (42 days)

    Product Code
    CHH
    Regulation Number
    862.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992842
    Device Name
    HICHEM ISE ELECTROLYTE REFERENCE
    Manufacturer
    ELAN HOLDINGS, INC.
    Date Cleared
    1999-11-26

    (94 days)

    Product Code
    JGS, CEM, CGZ, JFL, JFP
    Regulation Number
    862.1665
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HiChem® ISE Electrolyte Reference, when used in conjunction with the HiChem® ISE Electrolyte Buffer, HiChem® CO2 Acid Reagent, HiChem® CO2 Alkaline Buffer, HiChem® Wash Concentrate, and HiChem® Calibration Standards, is intended for the quantitative determination of sodium, chloride, and total CO2 in serum and plasma, and sodium, potassium and chloride in urine, and chloride in cerebrospinal fluid on the Beckman® CX® and CX® DELTA Systems. On appropriately configured SYNCHRON® CX® DELTA Systems, HiChem® ISE Electrolyte 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 insigidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiurelic hormone secretion, or other diseases involving electrolyte balance. 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 diagnosis and 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 senous 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 spasms). This reagent is intended for professional use only.
    Device Description
    Not Found
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    K Number
    K992844
    Device Name
    HICHEM ISE ELECTROLYTE BUFFER
    Manufacturer
    ELAN HOLDINGS, INC.
    Date Cleared
    1999-11-26

    (94 days)

    Product Code
    JGS, CEM, CGE, JFL, JFP
    Regulation Number
    862.1665
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HiChem® ISE Electrolyte Buffer, when used in conjunction with the HiChem® ISE Electrolyte Reference, HiChem® CO2 Acid Reagent, HiChem® CO2 Alkaline Buffer, HiChem® Wash Concentrate, and HiChem® Calibration Standards, is intended for the quantitative determination of sodium, chloride, and total CO2 in serum and plasma, and sodium, potassium and chloride in urine, and chloride in cerebrospinal fluid on the Beckman® CX® and CX® DELTA Systems. On appropriately configured SYNCHRON® CX® DELTA Systems, HiChem® ISE Electrolyte Buffer 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 destruction of the adrenal glands), dehydration, inappropriate antidiurelic hormone secretion, or other diseases involving electrolyte balance. 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 diagnosis and 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 senous 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 spasms). This reagent is intended for professional use only.
    Device Description
    HiChem® ISE Electrolyte Buffer is intended for the quantitative determination of sodium, potassium, chloride, and total CC2 in serum and plasma, and sodium, potassium and chloride in urine, and chloride in cerebrospinal fluid on the Beckman® SYNCHRON® CX® and CX® DELTA Systems. On appropriately configured SYNCHRON® CX® DELTA Systems. HiChem® ISE Electrolyte Buffer will also determine calcium in serum, plasma and urine.
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    K Number
    K992845
    Device Name
    HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT
    Manufacturer
    ELAN HOLDINGS, INC.
    Date Cleared
    1999-10-18

    (55 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HiChem® Calibrators 1, 2 and 3 are intended to calibrate the Beckman® SYNCHRON CX® DELTA and CX® CE® Systems for the quantitative determination of sodium, potassium, chloride, urea, giucose, creatinine, calcium and total CO2. HiChem® Calibrators 1, 2 and 3 for the SYNCHRON CX® DELTA and CX® CE® Systems are intended to establish points of reference that are used in the determination of values in the measurement of substances in specimens.
    Device Description
    Not Found
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    K Number
    K992846
    Device Name
    HICHEM TOTAL PROTEIN REAGENT
    Manufacturer
    ELAN HOLDINGS, INC.
    Date Cleared
    1999-10-18

    (55 days)

    Product Code
    CEK
    Regulation Number
    862.1635
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems. Total protein results are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This reagent is intended for professional use only.
    Device Description
    HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems.
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    K Number
    K992847
    Device Name
    HICHEM BUN REAGENT
    Manufacturer
    ELAN HOLDINGS, INC.
    Date Cleared
    1999-10-14

    (51 days)

    Product Code
    LFP
    Regulation Number
    862.1770
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems. Urea nitrogen results are used in the treatment of numerous renal and metabolic diseases. This reagent is intended for professional use only.
    Device Description
    HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems.
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