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510(k) Data Aggregation
K Number
K982469Device Name
HICHEM CHOLESTEROL REAGENT KIT
Manufacturer
Date Cleared
1998-08-19
(35 days)
Product Code
Regulation Number
862.1175Why did this record match?
Applicant Name (Manufacturer) :
ELAN PHARMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HiChem Cholesterol Reagent is intended for the quantitative determination of total cholesterol in serum and plasma for the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Device Description
The HiChem Cholesterol Reagent determines cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase. The resulting increase in absorbance at one of interested estable concessed on concentration in the sample.
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K Number
K981769Device Name
HICHEM PHOSPHORUS REAGENT KIT
Manufacturer
Date Cleared
1998-06-29
(41 days)
Product Code
Regulation Number
862.1580Why did this record match?
Applicant Name (Manufacturer) :
ELAN PHARMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HiChem Phosphorus Reagent is intended for the quantitative determination of inorganic phosphorus in serum, plasma and urine for the diagnosis and treatment of various disorders including parathyroid gland and kidney diseases, and vitamin D imbalance.
Device Description
The HiChem Phosphorus Reagent determines phosphorus by its reaction with molybdate in an acidic solution to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.
The HiChem Phosphorus Reagent is an adaptation of the method first described by Simonsen and is intended for use with manual spectrophotometers or clinical analyzers which can automate the required manipulations.
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K Number
K962247Device Name
HICHEM CK/NAC REAGENT KIT
Manufacturer
Date Cleared
1996-08-15
(65 days)
Product Code
Regulation Number
862.1215Why did this record match?
Applicant Name (Manufacturer) :
ELAN PHARMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HiChem CK/NAC Reagent (product no. 70003) is intended for the quantitation of creatine kinase in serum and n homent of had not headly no room, seevated serum creatine kinase are diseases of the heart and skeletal muscle.
Device Description
The HiChem CK/NAC Reagent determines creatine kinase by enzymation of adenosine diphosphate in the The rionoment of creatine the sphosphate. The rate of this reaction, and the activity of creatine kinase in the sociment is determined through the measurement of NADH which is formed through a series of linked enzymatic reactions.
The HiChern CK/NAC Reagent is intended to be used either as a manual procedure or on clinical analyzers which can THE HONEY ON WO Treagon IS The reagent is supplied as two liquit-stable components which are combined, ether adomails no roquined manyalance "The reason is to to series CK/NAC Reagent Buffer. The CK/NAC Bubstrate can also be used as a start reagent and combined with the Reagent Buffer following sample addition.
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K Number
K960115Device Name
HICHEM BUN/UREA REAGENT KIT
Manufacturer
Date Cleared
1996-03-29
(78 days)
Product Code
Regulation Number
862.1770Why did this record match?
Applicant Name (Manufacturer) :
ELAN PHARMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
for the quantitative determination of urea nitrogen in serum. plasma and urine.
Device Description
The HiChem BUN/Urea Reagent determines urea nitrogen through enzymatic hydrolysis by urease. The rate of this reaction, and the quantity of urea nitrogen in the specimen is monitored through the measurement of the resulting ammonia which oxidizes NADH to NAD in the presence of ox-keto-glutarate and glutamate dehydrogenase. The reagent is supplied as two liquid-stable reagent components which are intended to be combined, either before or during use, in the approximate ratio of 1 part BUN/Urea Enzyme Reagent and 5 parts BUN/Urea Buffer. The BUN/Urea Enzyme Reagent can also be used as a start reagent and combined with the reagent buffer after sample addition.
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