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510(k) Data Aggregation
K Number
K960084Device Name
HICHEM GLUCOSE/HK REAGENT KIT
Manufacturer
HI CHEM, INC.
Date Cleared
1996-04-04
(84 days)
Product Code
CFR
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
HI CHEM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HiChem Glucose/HK Reagent (product no. 70007) is for the quantitative determination of glucose in serum, plasma, cerebrospinal fluid and urine.
Device Description
The HiChem Glucose/HK Reagent determines glucose by enzymatic phosphorylation using ATP in the presence of hexokinase. The extent of this reaction, and the quantity of glucose in the specimen, is determined through the measurement of the resulting glucose-o-phosphate by producing NADH in the presence of glucose-o-phosphate dehydrogenase. The reagent is supplied as two liquid-stable components which are combined, either before or during use, in the approximate ratio of 1 part Glucose Enzyme Reagent and 8 parts Glucose Reagent Buffer. The Glucose Enzyme Reagent can also be used as a start reagent and combined with the Reagent Buffer following sample addition.
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