FDA Registration
Active
🇺🇸 United States
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
Reg #: 1832216
·
FEI: 1832216
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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
- K152835
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 |
|---|---|---|---|---|---|
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2016-04-20 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2016-04-20 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2016-04-20 |
Proprietary Names
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
Establishment Types
Manufacture Medical Device