FDA Registration
Active
🇺🇸 United States
Potassium Electrode, REF 3918-005
Reg #: 1717966
·
FEI: 1717966
·
Expires 2025
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- ELITechGroup Inc
- Registration Number
- 1717966
- FEI Number
- 1717966
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 370 West 1700 South
- City
- LOGAN
- State
- UT
- ZIP
- 84321
- Country
- US
Regulatory Submissions
- 510(k) Number
- K102647
Owner / Operator
- Firm Name
- ELITechGroup Inc.
- Operator Number
- 1717966
- Address
- 370 West 1700 South
- City
- Logan
- State
- UT
- Postal Code
- 84321
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2011-03-31 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2011-03-31 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2011-03-31 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2011-03-31 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2011-03-31 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2011-03-31 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2011-03-31 |
Proprietary Names
Potassium Electrode, REF 3918-005
Chloride Electrode, REF 3918-006
Sodium Electrode, REF 3918-004
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)