FDA Registration
Active
🇺🇸 United States
CS/CC CD3(IgG1)-RD1
Reg #: 1061932
·
FEI: 3000203293
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BECKMAN COULTER, INC.
- Registration Number
- 1061932
- FEI Number
- 3000203293
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11800 SW 147TH AVE.
- City
- Miami
- State
- FL
- ZIP
- 33196
- Country
- US
Regulatory Submissions
- 510(k) Number
- K911793
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2012-09-12 |
Proprietary Names
CS/CC CD3(IgG1)-RD1
CC CD3(IgG1)-RD1
CS/CC MsIgG1-FITC
CC MsIgG1 Isotypic Control
CC MsIgG1-RD1
CC CD3(IgG1)-FITC
CC MsIgG1-FITC
CS/CC CD3(IgG1)-FITC
CS/CC MsIgG1-RD1
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility