FDA Registration
Active
🇺🇸 United States
GEM Premier 5000 PAK
Reg #: 1217183
·
FEI: 1217183
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
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
- K160415
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 |
|---|---|---|---|---|---|
| Instrument, Hematocrit, Automated | GKF | Class 2 | Hematology | No | 2017-02-14 |
| Oximeter To Measure Hemoglobin | GLY | Class 2 | Hematology | No | 2017-02-14 |
| Assay, Carboxyhemoglobin | GHS | Class 2 | Hematology | No | 2017-02-14 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2017-02-14 |
Proprietary Names
GEM Premier 5000 PAK
Establishment Types
Manufacture Medical Device