FDA Registration
Active
🇺🇸 United States
SELECTALYTE
Reg #: 1036223
·
FEI: 1036223
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- AWARENESS TECHNOLOGY, INC.
- Registration Number
- 1036223
- FEI Number
- 1036223
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1935 S.W. MARTIN HWY.
- City
- PALM CITY
- State
- FL
- ZIP
- 34990
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171476
Owner / Operator
- Firm Name
- AWARENESS TECHNOLOGY, INC.
- Operator Number
- 1036223
- Address
- 1935 S.W. MARTIN HWY., --
- City
- Palm City
- State
- FL
- Postal Code
- 34990
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2018-08-15 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2018-08-15 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2018-08-15 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2018-08-15 |
Proprietary Names
SELECTALYTE
Establishment Types
Manufacture Medical Device