GLUCOSE TOLERANCE BEVERAGE
FDA 510(k) clearance K042183 · decided 2004-10-27
Clearance details
- K-number
- K042183
- Device name
- GLUCOSE TOLERANCE BEVERAGE
- Applicant
- Ever Scientific
- Decision
- Substantially Equivalent
- Date received
- 2004-08-11
- Decision date
- 2004-10-27
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- MRV
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Chester Springs, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EASYDEX (K120247) | Vineland Syrup, Inc. | 2012-06-21 |
| GLUCOSE TOLERANCE BEVERAGE (K032753) | Perk Scientific, Inc. | 2003-11-18 |
Recalls involving this device
No recalls on record reference this clearance.