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510(k) Data Aggregation
K Number
K973676Device Name
PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH
Manufacturer
Date Cleared
1997-12-16
(81 days)
Product Code
Regulation Number
862.1660Why 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
K973677Device Name
DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH
Manufacturer
Date Cleared
1997-12-15
(80 days)
Product Code
Regulation Number
862.1660Why 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
K973678Device Name
ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH
Manufacturer
Date Cleared
1997-12-15
(80 days)
Product Code
Regulation Number
862.1660Why 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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