Drink, Glucose Tolerance
The Glucose Tolerance Drink is a clinical chemistry device consisting of a standardized oral glucose solution administered to patients prior to glucose tolerance testing, used to diagnose diabetes mellitus, gestational diabetes, and other glucose metabolism disorders. Classified as FDA Class 2 under 21 CFR 862.1345 in the Clinical Chemistry specialty, it is 510(k)-exempt and subject to general controls. The product code is MRV.
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Basic Information
- Product Code
- MRV
- Device Class
- FDA class 2
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K120247 | EASYDEX | Jun 21, 2012 | Substantially Equivalent | Vineland Syrup, Inc. |
| K042183 | GLUCOSE TOLERANCE BEVERAGE | Oct 27, 2004 | Substantially Equivalent | Ever Scientific |
| K032753 | GLUCOSE TOLERANCE BEVERAGE | Nov 18, 2003 | Substantially Equivalent | Perk Scientific, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.