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510(k) Data Aggregation
K Number
K042183Device Name
GLUCOSE TOLERANCE BEVERAGE
Manufacturer
EVER SCIENTIFIC
Date Cleared
2004-10-27
(77 days)
Product Code
MRV
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EVER SCIENTIFIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Glucose Drink is a flavored beverage containing specific amounts of dextrose (D-glucose). Manufactured beverages contain three different amounts of glucose; 50,75, and 100 grams quantities per 10 oz bottle. This product is consumed in the In Vitro Diagnostic Glucose Tolerance Test for the detection of glucose intolerance in the evaluation of diabetes mellitus and other related illnesses.
Device Description
Glucose Drink is a water-based non-carbonated flavored beverage containing specific quantities of dextrose. We are marketing three flavors; orange, fruit punch, and lemonlime. Each flavor will have glucose concentrations of 50, 75, 100 grams of D-glucose per 10 oz bottle.
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