FDA Registration
Active
🇺🇸 United States
CBC-CAL Plus for Mindray
Reg #: 2182501
·
FEI: 2182501
·
Expires 2025
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- R & D SYSTEMS, INC.
- Registration Number
- 2182501
- FEI Number
- 2182501
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 614 MCKINLEY PL., N.E.
- City
- MINNEAPOLIS
- State
- MN
- ZIP
- 55413
- Country
- US
Regulatory Submissions
- 510(k) Number
- K955925
Owner / Operator
- Firm Name
- R & D SYSTEMS, INC.
- Operator Number
- 2182501
- Address
- 614 MCKINLEY PL., N.E., --
- City
- Minneapolis
- State
- MN
- Postal Code
- 55413
- Country
- US
- Correspondent
- Mary Anne Williams
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrator For Cell Indices | KRX | Class 2 | Hematology | No | 2009-11-01 |
| Calibrator For Red-Cell And White-Cell Counting | KSA | Class 2 | Hematology | No | 2009-11-01 |
| Calibrator For Platelet Counting | KRY | Class 2 | Hematology | No | 2009-11-01 |
| Calibrator For Hemoglobin And Hematocrit Measurement | KRZ | Class 2 | Hematology | No | 2009-11-01 |
Proprietary Names
CBC-CAL Plus for Mindray
NEK-CAL
CBC-CAL Plus
CBC-CAL Plus for Abacus
Establishment Types
Manufacture Medical Device