FDA Registration
Active
🇺🇸 United States
378020 High Sensitivity Cardiac C-Reactive Protein Reagent (CRPH 2 x 200)
Reg #: 2050010
·
FEI: 2050010
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BECKMAN COULTER, INC.
- Registration Number
- 2050010
- FEI Number
- 2050010
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2470 Faraday Ave
- City
- CARLSBAD
- State
- CA
- ZIP
- 92010
- Country
- US
Regulatory Submissions
- 510(k) Number
- K070626
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 |
|---|---|---|---|---|---|
| Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | NQD | Class 2 | Immunology | No | 2008-05-29 |
Proprietary Names
378020 High Sensitivity Cardiac C-Reactive Protein Reagent (CRPH 2 x 200)
Synchron CRPH reagent
Part numbers include, but are not limited to
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)