FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSE TOLERANCE BEVERAGE
K Number: K032753
·
Decision Nov 18, 2003
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
2
Applicant Total
1
Review Days
74
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GLUCOSE TOLERANCE BEVERAGE
- K Number
- K032753
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Perk Scientific, Inc.
- Date Received
- September 5, 2003
- Decision Date
- November 18, 2003
- Product Code
- MRV
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRV | Drink, Glucose Tolerance | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRV), ordered by most recent decision date.
EASYDEX
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GLUCOSE TOLERANCE BEVERAGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry