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510(k) Data Aggregation

    K Number
    K973676
    Device Name
    PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH
    Date Cleared
    1997-12-16

    (81 days)

    Product Code
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SORRENTO BIOCHEMICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prestiae Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit.
    Device Description
    Prestige Aqueous Glucose Control Low Prestige Agueous Glucose Control High
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    K Number
    K973677
    Device Name
    DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH
    Date Cleared
    1997-12-15

    (80 days)

    Product Code
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SORRENTO BIOCHEMICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diascan Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit. Glucose monitoring has become a major adjunct to the care of individuals with diabetes mellitus in the past decade. It is now possible for the individual with diabetes and the health-care professional to measure and record blood glucose levels frequently with portable devices. In the hospital, blood glucose monitor kits are often used instead of routine laboratory glucose testing methods to quickly obtain blood glucose concentrations from patients in the ER, ICU. CCU. OR, or other bedside locations. Used at home, these kits allow individuals with diabetes to monitor and treat fluctuations in blood glucose levels daily.
    Device Description
    Diascan Aqueous Glucose Control Low Diascan Aqueous Glucose Control High
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    K Number
    K973678
    Device Name
    ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH
    Date Cleared
    1997-12-15

    (80 days)

    Product Code
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SORRENTO BIOCHEMICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ultra + Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit.
    Device Description
    Ultra + Aqueous Glucose Control Low and Ultra + Aqueous Glucose Control High are ready to use solutions, which contain a specific amount of glucose.
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