FDA Registration
Active
🇯🇵 Japan
DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module, C63522
Reg #: 9612296
·
FEI: 3002807663
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Beckman Coulter Mishima K.K.
- Registration Number
- 9612296
- FEI Number
- 3002807663
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 454-32 HIGASHINO,NAGAIZUMI-CHO
- City
- SUNTO-GUN Shizuoka
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K242190
Owner / Operator
- Firm Name
- BECKMAN COULTER, INC.
- Operator Number
- 2050012
- Address
- 250 S. Kraemer Blvd, --
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2025-03-07 |
Proprietary Names
DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module, C63522
DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module, C13252
DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module, C63521
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)