FDA Registration
Active
🇺🇸 United States
Roche ISE Standard
Reg #: 2085064
·
FEI: 1000135102
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- CLINIQA CORPORATION
- Registration Number
- 2085064
- FEI Number
- 1000135102
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 495 Enterprise Street
- City
- San Marcos
- State
- CA
- ZIP
- 92078
- Country
- US
Regulatory Submissions
- 510(k) Number
- K953239
Owner / Operator
- Firm Name
- CLINIQA CORPORATION
- Operator Number
- 2083131
- Address
- 495 Enterprise Street, --
- City
- San Marcos
- State
- CA
- Postal Code
- 92078
- Country
- US
- Correspondent
- Dawn - Gast
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2010-07-20 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2010-07-20 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2010-07-20 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2010-07-20 |
Proprietary Names
Roche ISE Standard
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)