FDA Registration
Active
🇺🇸 United States
AgaMatrix
Reg #: 1000115322
·
FEI: 1000115322
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Sixarp LLC, Praxis
- Registration Number
- 1000115322
- FEI Number
- 1000115322
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7650 Caterpillar Ct SW Ste D
- City
- Grand Rapids
- State
- MI
- ZIP
- 49548
- Country
- US
Regulatory Submissions
- 510(k) Number
- K072413
Owner / Operator
- Firm Name
- Sixarp LLC, Praxis
- Operator Number
- 10031872
- Address
- 7650 Caterpillar Dr, Suite D
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49548
- Country
- US
- Correspondent
- John Lowry
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2011-12-09 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2011-12-09 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2011-12-09 |
Proprietary Names
AgaMatrix
Establishment Types
Repack or Relabel Medical Device