FDA Registration
Active
🇺🇸 United States
Biotronix Healthcare Bio-Q Plus Blood Glucose Monitoring System
Reg #: 3010131137
·
FEI: 3010131137
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Registration Number
- 3010131137
- FEI Number
- 3010131137
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4700 Millenia Blvd Ste 500
- City
- Orlando
- State
- FL
- ZIP
- 32839
- Country
- US
Regulatory Submissions
- 510(k) Number
- K102316
Owner / Operator
- Firm Name
- Biotronix Healthcare Industries Inc.
- Operator Number
- 10043487
- Address
- 4700 Millenia Blvd Suite 500
- City
- Orlando
- State
- FL
- Postal Code
- 32839
- 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 | 2015-06-14 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2015-06-14 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2015-06-14 |
Proprietary Names
Biotronix Healthcare Bio-Q Plus Blood Glucose Monitoring System
Biotronix Healthcare Bio-Q One Blood Glucose Monitoring System
Establishment Types
Repack or Relabel Medical Device