FDA Registration
Active
🇺🇸 United States
GEM Premier 3500
Reg #: 1217183
·
FEI: 1217183
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- INSTRUMENTATION LABORATORY CO.
- Registration Number
- 1217183
- FEI Number
- 1217183
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 180 Hartwell Rd.
- City
- Bedford
- State
- MA
- ZIP
- 01730
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161818
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 |
|---|---|---|---|---|---|
| Antiserum, Positive Control, Aspergillus Spp. | KFG | Class 1 | Microbiology | No | 2018-02-20 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2018-02-20 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2018-02-20 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2018-02-20 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2018-02-20 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2018-02-20 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2018-02-20 |
Proprietary Names
GEM Premier 3500
Establishment Types
Manufacture Medical Device