FDA Registration
Active
🇺🇸 United States
TC-Thunderbolt automated urine analyzer system
Reg #: 1832216
·
FEI: 1832216
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
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
- K141289
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 |
|---|---|---|---|---|---|
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2015-11-04 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2015-11-04 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2015-11-04 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2015-11-04 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2015-11-04 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2015-11-04 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2015-11-04 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2015-11-04 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2015-11-04 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2015-11-04 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2015-11-04 |
Proprietary Names
TC-Thunderbolt automated urine analyzer system
Establishment Types
Manufacture Medical Device