FDA device listing
RX IMOLA
FDA device listing 1207598659 · RANDOX LABORATORIES, LTD.
Key facts
| Proprietary names | RX IMOLA |
|---|---|
| Owner/operator | RANDOX LABORATORIES, LTD. |
| Owner/operator number | 8020890 |
| Premarket submissions | K052914 |
| Product codes | CEM, CGZ, JGJ, JGS, JJE |
| Device names | CEM - Electrode, Ion Specific, Potassium, CGZ - Electrode, Ion-Specific, Chloride, JGJ - Photometric Method, Magnesium, JGS - Electrode, Ion Specific, Sodium, JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1170, 862.1495, 862.1600, 862.1665, 862.2160 |
| Review panels | Clinical Chemistry |
| Registered establishments | RANDOX LABORATORIES LIMITED, Randox Teoranta |
| Establishment registrations | 3004493545, 3009473156, 3014607865 |
| FEI numbers | 3004493545, 3009473156, 3014607865 |
| Establishment operations | Foreign Private Label Distributor, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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