FDA Registration
Active
🇺🇸 United States
GE Diabetes Management System
Reg #: 3006755541
·
FEI: 3006755541
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- BIONIME USA CORPORATION
- Registration Number
- 3006755541
- FEI Number
- 3006755541
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1450 E. Spruce Street, Bldg. #B
- City
- Ontario
- State
- CA
- ZIP
- 91761
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133522
Owner / Operator
- Firm Name
- BIONIME USA CORPORATION
- Operator Number
- 10024947
- Address
- 1450 E. Spruce Street, Bldg. #B
- City
- Ontario
- State
- CA
- Postal Code
- 91761
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2014-12-04 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2014-12-04 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2014-12-04 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2014-12-04 |
Proprietary Names
GE Diabetes Management System
Bionime Rightest Diabetes Management System
Establishment Types
Complaint File Establishment per 21 CFR 820.198