FDA Registration
Active
🇩🇪 Germany
A11036 Power Processor Sample Processing System
Reg #: 3006677029
·
FEI: 3006677029
·
Expires 2025
Products
5
Proprietary Names
3
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Beckman Coulter Biomedical GmbH
- Registration Number
- 3006677029
- FEI Number
- 3006677029
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Sauerbruchstr. 50
- City
- Munchen Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K110413
Owner / Operator
- Firm Name
- BECKMAN COULTER, INC.
- Operator Number
- 2050012
- Address
- 250 S. Kraemer Blvd, --
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
- Correspondent
- David G Davis
US Agent
- Business Name
- Beckman Coulter, Inc.
- Contact Name
- David Davis
- Address
- 250 S. Kraemer Blvd
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 469 2368180
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2013-02-08 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2013-02-08 |
| Radioassay, Vitamin B12 | CDD | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2013-02-08 |
Proprietary Names
A11036 Power Processor Sample Processing System
Power Processor PowerCel
B05033 Power Link
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility