GLUCOSE TOLERANCE BEVERAGE— 510(k) K042183
Substantially EquivalentEver Scientific
FDA 510(k) clearance K042183 for GLUCOSE TOLERANCE BEVERAGE, Substantially Equivalent on 2004-10-27. Applicant: Ever Scientific. Device class: 2.
Clearance details
- Applicant
- Ever Scientific
- Product code
- Code MRV
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chester Springs, PA, US
Recent devices under product code MRV
view allRecalls naming K042183
K-number listed on FDA's recall record- Z-0329-2017 — Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.
- Z-0330-2017 — Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042183.
Data sourced from openFDA. This site is unofficial and independent of the FDA.