FDA Registration
Active
🇺🇸 United States
TC-Matrix Chemistry Analyzer
Reg #: 1832216
·
FEI: 1832216
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- TECO DIAGNOSTICS
- Registration Number
- 1832216
- FEI Number
- 1832216
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1268 NORTH LAKEVIEW AVE.
- City
- ANAHEIM
- State
- CA
- ZIP
- 92807
- Country
- US
Regulatory Submissions
- 510(k) Number
- K073370
Owner / Operator
- Firm Name
- TECO DIAGNOSTICS
- Operator Number
- 1832216
- Address
- 1268 NORTH LAKEVIEW AVE., --
- City
- Anaheim
- State
- CA
- Postal Code
- 92807
- Country
- US
- Correspondent
- KC Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2009-04-02 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2009-04-02 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2009-04-02 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2009-04-02 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2009-04-02 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2009-04-02 |
Proprietary Names
TC-Matrix Chemistry Analyzer
Establishment Types
Manufacture Medical Device