GLUCOSE TOLERANCE BEVERAGE
FDA 510(k) clearance K032753 · decided 2003-11-18
Clearance details
- K-number
- K032753
- Device name
- GLUCOSE TOLERANCE BEVERAGE
- Applicant
- Perk Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-05
- Decision date
- 2003-11-18
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- MRV
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Yeadon, 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 (K042183) | Ever Scientific | 2004-10-27 |
Recalls involving this device
No recalls on record reference this clearance.