FDA Registration
Active
🇺🇸 United States
EX-CAL Hematology Calibrator
Reg #: 1064608
·
FEI: 3003071743
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- JAS Diagnostics/Drew Scientific
- Registration Number
- 1064608
- FEI Number
- 3003071743
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6600 NW 14th Street, BAY 12
- City
- Plantation
- State
- FL
- ZIP
- 33313
- Country
- US
Regulatory Submissions
- 510(k) Number
- K003991
Owner / Operator
- Firm Name
- JAS Diagnostics/Drew Scientific
- Operator Number
- 9042128
- Address
- 6600 NW 14th Street, BAY 12
- City
- Plantation
- State
- FL
- Postal Code
- 33313
- Country
- US
- Correspondent
- Jean F LaCroix
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrator For Red-Cell And White-Cell Counting | KSA | Class 2 | Hematology | No | 2016-08-09 |
| Calibrator For Platelet Counting | KRY | Class 2 | Hematology | No | 2016-08-09 |
| Calibrator For Cell Indices | KRX | Class 2 | Hematology | No | 2016-08-09 |
| Calibrator For Hemoglobin And Hematocrit Measurement | KRZ | Class 2 | Hematology | No | 2016-08-09 |
Proprietary Names
EX-CAL Hematology Calibrator
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility