FDA Registration
Active
🇺🇸 United States
AutoMate 1200 Sample Processing System
Reg #: 1061932
·
FEI: 3000203293
·
Expires 2025
Products
1
Proprietary Names
18
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
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 |
|---|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2000-10-04 |
Proprietary Names
AutoMate 1200 Sample Processing System
AutoMate 2500 Sample Processing System
AutoMate 2550 Sample Processing System
ODL25255 AutoMate 2550 LAB INSTRUMENT
AutoMate 1250 Sample Processing System
ODL25120 AutoMate 1200 LAB INSTRUMENT
ODL25125 AutoMate 1250 LAB INSTRUMENT
A18894 Automate 800 Sample Processing System
ODL25250 AutoMate 2500 LAB INSTRUMENT
Command Central
A18896 Automate 600 Sample Processing System
Kaluza C 10 User Network (PN C10576)
Kaluza C Perpetual License (PN C10574)
Kaluza C Single Use 1 Year License (PN C10575)
Kaluza C Flow Cytometry Software (PN C21166)
Kaluza C 5 User Network (PN C10577)
DxOne Workflow Manager
REMISOL ADVANCE
Establishment Types
Manufacture Medical Device