FDA Registration
Active
🇺🇸 United States
CareSens N Voice Blood Glucose Monitoring System
Reg #: 3008780388
·
FEI: 3008780388
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- I-SENS USA, INC.
- Registration Number
- 3008780388
- FEI Number
- 3008780388
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3545 Lomita Blvd., Unit D
- City
- Torrance
- State
- CA
- ZIP
- 90505
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121133
Owner / Operator
- Firm Name
- i-SENS USA, Inc.
- Operator Number
- 10034826
- Address
- 3545 Lomita Blvd., Unit D
- City
- Torrance
- State
- CA
- Postal Code
- 90505
- Country
- US
- Correspondent
- Jeonghan Ha
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2022-01-10 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2022-01-10 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2022-01-10 |
Proprietary Names
CareSens N Voice Blood Glucose Monitoring System
Establishment Types
Complaint File Establishment per 21 CFR 820.198