FDA Registration
Active
🇯🇵 Japan
cobas pure integrated solutions
Reg #: 9614673
·
FEI: 3003559576
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- HITACHI HIGH-TECH CORP., NAKA DIVISION
- Registration Number
- 9614673
- FEI Number
- 3003559576
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 882 ICHIGE
- City
- Hitachinaka-shi Ibaraki
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K220134
Owner / Operator
- Firm Name
- HITACHI HIGH-TECH CORP.
- Operator Number
- 9049564
- Address
- 1-17-1 Toranomon,, --
- City
- Minato-ku
- State
- Tokyo
- Postal Code
- 105-6409
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2022-09-25 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2022-09-25 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2022-09-25 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2022-09-25 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2022-09-25 |
Proprietary Names
cobas pure integrated solutions
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)