FDA Registration
Active
🇺🇸 United States
HbA1c DIRECT ENZYMATIC TEST KIT
Reg #: 1832216
·
FEI: 1832216
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
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
- K050178
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 |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-06-10 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2013-06-10 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2013-06-10 |
Proprietary Names
HbA1c DIRECT ENZYMATIC TEST KIT
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device