FDA Registration
Active
🇺🇸 United States
GEM SYSTEM EVALUATOR 1, 2, 3
Reg #: 2431530
·
FEI: 2431530
·
Expires 2025
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- INSTRUMENTATION LABORATORY CO.
- Registration Number
- 2431530
- FEI Number
- 2431530
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 526 Route 303
- City
- ORANGEBURG
- State
- NY
- ZIP
- 10962
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160225
Owner / Operator
- Firm Name
- Instrumentation Laboratory Co.
- Operator Number
- 1217183
- Address
- 180 Hartwell Road, --
- City
- Bedford
- State
- MA
- Postal Code
- 01730
- Country
- US
- Correspondent
- Carol - Marble
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2017-02-14 |
| Control, Hematocrit | GLK | Class 2 | Hematology | No | 2017-02-14 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2017-02-14 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2017-02-14 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2017-02-14 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2017-02-14 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2017-02-14 |
Proprietary Names
GEM SYSTEM EVALUATOR 1, 2, 3
GEM CVP 5 tBILI
GEM HEMATOCRIT EVALUATOR 1, 2, 3
Establishment Types
Manufacture Medical Device