FDA Registration
Active
🇺🇸 United States
465300 Immunochemistry Systems Level 2 Urine Protein Control
Reg #: 2050012
·
FEI: 2050012
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BECKMAN COULTER, INC.
- Registration Number
- 2050012
- FEI Number
- 2050012
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 250 S Kraemer Blvd
- City
- BREA
- State
- CA
- ZIP
- 92821
- Country
- US
Regulatory Submissions
- 510(k) Number
- K951635
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 |
|---|---|---|---|---|---|
| Method, Nephelometric, Immunoglobulins (G, A, M) | CFN | Class 2 | Immunology | No | 2013-02-18 |
| Igg, Antigen, Antiserum, Control | DEW | Class 2 | Immunology | No | 2013-02-18 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2013-02-18 |
Proprietary Names
465300 Immunochemistry Systems Level 2 Urine Protein Control
465290 Immunochemistry Systems Level 1 Urine Protein Control
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility