FDA Registration
Active
🇺🇸 United States
FORA GD50 Blood Glucose Monitoring System
Reg #: 3007134734
·
FEI: 3007134734
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- FORA CARE INC.
- Registration Number
- 3007134734
- FEI Number
- 3007134734
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 893 Patriot Dr Ste D
- City
- Moorpark
- State
- CA
- ZIP
- 93021
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100322
Owner / Operator
- Firm Name
- Fora Care Inc.
- Operator Number
- 10026431
- Address
- 893 Patriot Dr., Suite D
- City
- Moorpark
- State
- CA
- Postal Code
- 93021
- Country
- US
- Correspondent
- G.L. Liu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2015-12-09 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2015-12-09 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2015-12-09 |
Proprietary Names
FORA GD50 Blood Glucose Monitoring System
FORA Test N'GO Voice Blood Glucose Monitoring System
FORA TN'G Voice Blood Glucose Monitoring System
Establishment Types
Complaint File Establishment per 21 CFR 820.198