FDA Registration
Active
🇺🇸 United States
ABL80 FLEX CO-OX with AQURE
Reg #: 3014506106
·
FEI: 3014506106
·
Expires 2025
Products
10
Proprietary Names
1
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Radiometer Minneapolis
- Registration Number
- 3014506106
- FEI Number
- 3014506106
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 121 5th Avenue W
- City
- New Brighton
- State
- MN
- ZIP
- 55112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151856
Owner / Operator
- Firm Name
- RADIOMETER MEDICAL APS
- Operator Number
- 8020503
- Address
- AAKANDEVEJ 21, --
- City
- BROENSHOEJ
- State
- Hovedstaden
- Postal Code
- 2700
- Country
- DK
- Correspondent
- Hsiao-Qing Chow
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2022-06-28 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2022-06-28 |
| Device, Hematocrit Measuring | JPI | Class 2 | Hematology | No | 2022-06-28 |
| Assay, Carboxyhemoglobin | GHS | Class 2 | Hematology | No | 2022-06-28 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2022-06-28 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2022-06-28 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2022-06-28 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-06-28 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2022-06-28 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2022-06-28 |
Proprietary Names
ABL80 FLEX CO-OX with AQURE
Establishment Types
Manufacture Medical Device