FDA Registration
Active
🇺🇸 United States
iGlucose Blood Glucose Monitoring System
Reg #: 3015489159
·
FEI: 3015489159
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ALOM Technologies Corporation
- Registration Number
- 3015489159
- FEI Number
- 3015489159
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3910 Waldemere Avenue
- City
- Indianapolis
- State
- IN
- ZIP
- 46241
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161790
Owner / Operator
- Firm Name
- ALOM TECHNOLOGIES CORPORATION
- Operator Number
- 9063998
- Address
- 48021 WARM SPRINGS BLVD., --
- City
- Fremont
- State
- CA
- Postal Code
- 94539
- Country
- US
- Correspondent
- Hannah - Kain
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2025-01-10 |
Proprietary Names
iGlucose Blood Glucose Monitoring System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)