FDA Registration
Active
🇺🇸 United States
XL-200/XL-400
Reg #: 1064608
·
FEI: 3003071743
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
2
Classifications
5
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
- K130915
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 |
|---|---|---|---|---|---|
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2018-03-02 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2018-03-02 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2018-03-02 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2018-03-02 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2018-03-02 |
Proprietary Names
XL-200/XL-400
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device