FDA Registration
Active
🇺🇸 United States
SYNCHRON UniCel DxC 600i, 800i, 660i, 860i
Reg #: 2050012
·
FEI: 2050012
·
Expires 2025
Products
18
Proprietary Names
12
Establishment Types
1
Classifications
18
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
- K060256
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 |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Igm, Antigen, Antiserum, Control | DFT | Class 2 | Immunology | No | 2013-02-08 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2013-02-08 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2013-02-08 |
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2013-02-08 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2013-02-08 |
| Radioimmunoassay (Two-Site Solid Phase), Ferritin | JMG | Class 2 | Immunology | No | 2013-02-08 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2013-02-08 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2013-02-08 |
Proprietary Names
SYNCHRON UniCel DxC 600i, 800i, 660i, 860i
A64872 UniCel DxC 660i - Full System
A64936 UniCel DxC 860i - Full System
A64868 Unicel DxC 660i Synchron Access Clinical System
A59102 Unicel DxC 880i Synchron Access Clinical System
A64904 UniCel DxC 680i - Full System
A64871 UniCel DxC 660i - Full System Domestic
A64903 UniCel DxC 680i - Full System Domestic
A64869 Unicel DxC 680i Synchron Access Clinical System
A64870 Unicel DxC 860i Synchron Access Clinical System
A27318 Unicel DxC 600i Synchron Access Clinical System
A64935 UniCel DxC 860i - Full System Domestic
Establishment Types
Manufacture Medical Device