FDA Registration
Active
🇯🇵 Japan
CRP-Latex (II) X2 SEIKEN Assay Kit
Reg #: 3003871639
·
FEI: 3003871639
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DENKA CO., LTD.
- Registration Number
- 3003871639
- FEI Number
- 3003871639
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1359-1, KAGAMIDA, KIGOSHI
- City
- GOSEN-SHI Niigata
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K030545
Owner / Operator
- Firm Name
- DENKA CO., LTD.
- Operator Number
- 9053049
- Address
- 1359-1, KAGAMIDA, KIGOSHI
- City
- GOSEN-SHI
- State
- Niigata
- Postal Code
- 959-1695
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2008-05-07 |
Proprietary Names
CRP-Latex (II) X2 SEIKEN Assay Kit
Establishment Types
Manufacture Medical Device