FDA Registration
Active
🇨🇳 China
URITEK TC-101 URINE ANALYZER
Reg #: 3006621318
·
FEI: 3006621318
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- Chong Qing Teco Huayi Pharm. Co.
- Registration Number
- 3006621318
- FEI Number
- 3006621318
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1st Std. Workshop 2-402, No. 98, Xiyuan 2nd Road, Shapingba Dist., Chongqing 401332
- City
- Shapingba Dist., Chongqing
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K101673
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
US Agent
- Business Name
- Teco Diagnostics
- Contact Name
- KC Chen
- Address
- 1268 N. Lakeview Ave
- City
- Anaheim
- State
- CA
- ZIP
- 92807
- Country
- US
- [email protected]
- Phone
- 714 4631111
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2011-02-16 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2011-02-16 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2011-02-16 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2011-02-16 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2011-02-16 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2011-02-16 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2011-02-16 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2011-02-16 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2011-02-16 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2011-02-16 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2011-02-16 |
Proprietary Names
URITEK TC-101 URINE ANALYZER
Establishment Types
Manufacture Medical Device