FDA Registration
Active
🇺🇸 United States
CareLiving Blood Glucose Meter
Reg #: 3031259044
·
FEI: 3031259044
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- CARE LIVING DIAGNOSTICS INC
- Registration Number
- 3031259044
- FEI Number
- 3031259044
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 43 Sunflower Ridge Rd
- City
- South Setauket
- State
- NY
- ZIP
- 11720
- Country
- US
Regulatory Submissions
- 510(k) Number
- K052208
Owner / Operator
- Firm Name
- Care Living Diagnostics Inc
- Operator Number
- 10090880
- Address
- 43 Sunflower Ridge Rd
- City
- South Setauket
- State
- NY
- Postal Code
- 11720
- Country
- US
- Correspondent
- Wendy Yang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2024-05-27 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2024-05-27 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2024-05-27 |
Proprietary Names
CareLiving Blood Glucose Meter
CareLiving Glucose Control Solution
GLUCOSE PILOT
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility