FDA Registration
Active
🇺🇸 United States
CELL-DYN HemCal Plus (LN 08H57-01)
Reg #: 3005333358
·
FEI: 3005333358
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ABBOTT LABORATORIES
- Registration Number
- 3005333358
- FEI Number
- 3005333358
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Conway Park, 675 North Field Drive
- City
- Lake Forest
- State
- IL
- ZIP
- 60045
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020469
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrator For Cell Indices | KRX | Class 2 | Hematology | No | 2020-01-10 |
| Calibrator For Platelet Counting | KRY | Class 2 | Hematology | No | 2020-01-10 |
| Calibrator For Red-Cell And White-Cell Counting | KSA | Class 2 | Hematology | No | 2020-01-10 |
| Calibrator For Hemoglobin And Hematocrit Measurement | KRZ | Class 2 | Hematology | No | 2020-01-10 |
Proprietary Names
CELL-DYN HemCal Plus (LN 08H57-01)
Alinity h-series HemCal (LN 04U7302)
Establishment Types
Complaint File Establishment per 21 CFR 820.198