FDA Registration
Active
🇺🇸 United States
GEM Premier 4000
Reg #: 2431530
·
FEI: 2431530
·
Expires 2025
Products
13
Proprietary Names
1
Establishment Types
1
Classifications
13
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
- K133407
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, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2023-07-25 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2023-07-25 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2023-07-25 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2023-07-25 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2023-07-25 |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | Class 1 | Clinical Chemistry | No | 2023-07-25 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2023-07-25 |
| Oximeter To Measure Hemoglobin | GLY | Class 2 | Hematology | No | 2023-07-25 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2023-07-25 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2023-07-25 |
| Instrument, Hematocrit, Automated | GKF | Class 2 | Hematology | No | 2023-07-25 |
| Assay, Carboxyhemoglobin | GHS | Class 2 | Hematology | No | 2023-07-25 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2023-07-25 |
Proprietary Names
GEM Premier 4000
Establishment Types
Manufacture Medical Device