FDA Registration
Active
🇺🇸 United States
GEM Premier ChemSTAT
Reg #: 3037000637
·
FEI: 3037000637
·
Expires 2025
Products
11
Proprietary Names
2
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- INSTRUMENTATION LABORATORY CO. - Devens
- Registration Number
- 3037000637
- FEI Number
- 3037000637
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 11 Grant Road
- City
- Devens
- State
- MA
- ZIP
- 01434
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223090
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, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2023-03-02 |
| Enzymatic, Carbon-Dioxide | KHS | Class 2 | Clinical Chemistry | No | 2023-03-02 |
| Instrument, Hematocrit, Automated | GKF | Class 2 | Hematology | No | 2023-03-02 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2023-03-02 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2023-03-02 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2023-03-02 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2023-03-02 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2023-03-02 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2023-03-02 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2023-03-02 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2023-03-02 |
Proprietary Names
GEM Premier ChemSTAT
GEM Premier ChemSTAT PAK
Establishment Types
Repack or Relabel Medical Device