FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSE TOLERANCE BEVERAGE
K Number: K042183
·
Decision Oct 27, 2004
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
2
Applicant Total
1
Review Days
77
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Basic Information
- Device Name
- GLUCOSE TOLERANCE BEVERAGE
- K Number
- K042183
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ever Scientific
- Date Received
- August 11, 2004
- Decision Date
- October 27, 2004
- 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.
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