FDA device listing
Carbon Dioxide Electrode, 275-001,Chloride Electrode, REF 280-001,Potassium Electrode, REF 279-001,Sodium Electrode, REF…
FDA device listing 1143812424 · ELITechGroup Inc.
Key facts
| Proprietary names | Carbon Dioxide Electrode, 275-001,Chloride Electrode, REF 280-001,Potassium Electrode, REF 279-001,Sodium Electrode, REF 278-001 |
|---|---|
| Owner/operator | ELITechGroup Inc. |
| Owner/operator number | 1717966 |
| Product codes | CEM, CGZ, CHH, CHL, JGS, JJE |
| Device names | CEM - Electrode, Ion Specific, Potassium, CGZ - Electrode, Ion-Specific, Chloride, CHH - Enzymatic Esterase--Oxidase, Cholesterol, CHL - Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, JGS - Electrode, Ion Specific, Sodium, JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1120, 862.1170, 862.1175, 862.1600, 862.1665, 862.2160 |
| Review panels | Clinical Chemistry |
| Registered establishments | ELITechGroup Inc |
| Establishment registrations | 1717966 |
| FEI numbers | 1717966 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database