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510(k) Data Aggregation

    K Number
    K960084
    Device Name
    HICHEM GLUCOSE/HK REAGENT KIT
    Manufacturer
    HI CHEM, INC.
    Date Cleared
    1996-04-04

    (84 days)

    Product Code
    CFR
    Regulation Number
    862.1345
    Why 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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