FDA Registration
Active
🇺🇸 United States
ContrIL 7 1, 2, 3 and Multipak
Reg #: 3012775350
·
FEI: 3012775350
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Instrumentation Laboratory Co.
- Registration Number
- 3012775350
- FEI Number
- 3012775350
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 18B Independence Dr
- City
- Devens
- State
- MA
- ZIP
- 01434
- Country
- US
Regulatory Submissions
- 510(k) Number
- K992834
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 |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2008-06-03 |
| Fluorometric, Calcium | JFO | Class 2 | Clinical Chemistry | No | 2008-06-03 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2008-06-03 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2008-06-03 |
| Instrument, Hematocrit, Automated | GKF | Class 2 | Hematology | No | 2008-06-03 |
Proprietary Names
ContrIL 7 1, 2, 3 and Multipak
GEM Crit Check
Establishment Types
Manufacture Device in the United States for Export Only
Repack or Relabel Medical Device