FDA Registration
Active
🇺🇸 United States
MicroScan Dried Gram Negative MIC/Combo Panels - Doripenem
Reg #: 2919016
·
FEI: 2919016
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Beckman Coulter, Inc.
- Registration Number
- 2919016
- FEI Number
- 2919016
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2040 ENTERPRISE BLVD.
- City
- West Sacramento
- State
- CA
- ZIP
- 95691
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101425
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 |
|---|---|---|---|---|---|
| Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | LRG | Class 2 | Microbiology | No | 2015-02-23 |
| Panels, Test, Susceptibility, Antimicrobial | LTT | Class 2 | Microbiology | No | 2015-02-23 |
| Manual Antimicrobial Susceptibility Test Systems | JWY | Class 2 | Microbiology | No | 2015-02-23 |
Proprietary Names
MicroScan Dried Gram Negative MIC/Combo Panels - Doripenem
Establishment Types
Manufacture Medical Device