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Found 12 results
510(k) Data Aggregation
K Number
K013152Device 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
862.1475Why 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
K012474Device Name
ATAC PAK CPK REAGENT KIT
Manufacturer
ELAN HOLDINGS, INC.
Date Cleared
2001-10-03
(62 days)
Product Code
CGS
Regulation Number
862.1215Why 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
K010488Device Name
ATAC PAK AST REAGENT KIT
Manufacturer
ELAN HOLDINGS, INC.
Date Cleared
2001-04-09
(48 days)
Product Code
CIT
Regulation Number
862.1100Why 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
K000958Device 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
862.1770Why 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
K000900Device 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
862.1175Why 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
K992842Device 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
862.1665Why 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
K992844Device 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
862.1665Why 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
K992845Device 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
862.1150Why 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
K992846Device Name
HICHEM TOTAL PROTEIN REAGENT
Manufacturer
ELAN HOLDINGS, INC.
Date Cleared
1999-10-18
(55 days)
Product Code
CEK
Regulation Number
862.1635Why 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
K992847Device Name
HICHEM BUN REAGENT
Manufacturer
ELAN HOLDINGS, INC.
Date Cleared
1999-10-14
(51 days)
Product Code
LFP
Regulation Number
862.1770Why 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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