FDA Registration
Active
🇺🇸 United States
GlycoMark
Reg #: 3016698405
·
FEI: 3016698405
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- PRECISION DIABETES, INC.
- Registration Number
- 3016698405
- FEI Number
- 3016698405
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5540 Centerview Drive, Suite 200
- City
- Raleigh
- State
- NC
- ZIP
- 27606
- Country
- US
Regulatory Submissions
- 510(k) Number
- K031604
Owner / Operator
- Firm Name
- Precision Diabetes, Inc.
- Operator Number
- 10068056
- Address
- 5540 Centerview Drive, Suite 200
- City
- Raleigh
- State
- NC
- Postal Code
- 27606
- Country
- US
- Correspondent
- Eric Button
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2020-04-08 |
| Assay, 1,5-Anhydroglucitol (15ag) | NOZ | Class 2 | Hematology | No | 2020-04-08 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2020-04-08 |
Proprietary Names
GlycoMark
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility