510(k) K042183
K042183 is an FDA 510(k) premarket notification submitted by Ever Scientific for the device "GLUCOSE TOLERANCE BEVERAGE". The FDA issued a decision of Substantially Equivalent on October 27, 2004. The device falls under product code MRV (Drink, Glucose Tolerance), a Class II device regulated under 21 CFR 862.1345.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2004
- Date Received
- August 11, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drink, Glucose Tolerance
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type