FDA Registration
Active
🇺🇸 United States
663940 Immunochemistry Systems CAL 2 Calibrator 2
Reg #: 2050012
·
FEI: 2050012
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
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
- K973932
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 |
|---|---|---|---|---|---|
| Antithrombin Iii Quantitation | JBQ | Class 2 | Hematology | No | 2013-02-06 |
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 2013-02-06 |
| Iga, Antigen, Antiserum, Control | CZP | Class 2 | Immunology | No | 2013-02-06 |
| Ceruloplasmin, Antigen, Antiserum, Control | DDB | Class 2 | Immunology | No | 2013-02-06 |
| Alpha-2-Macroglobulin, Antigen, Antiserum, Control | DEB | Class 2 | Immunology | No | 2013-02-06 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2013-02-06 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2013-02-06 |
Proprietary Names
663940 Immunochemistry Systems CAL 2 Calibrator 2
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility