FDA device listing
ABL90 FLEX PLUS
FDA device listing 1921015706 · RADIOMETER MEDICAL APS
Key facts
| Proprietary names | ABL90 FLEX PLUS |
|---|---|
| Owner/operator | RADIOMETER MEDICAL APS |
| Owner/operator number | 8020503 |
| Product codes | CEM, CGA, JFP, JGS, KHP |
| Device names | CEM - Electrode, Ion Specific, Potassium, CGA - Glucose Oxidase, Glucose, JFP - Electrode, Ion Specific, Calcium, JGS - Electrode, Ion Specific, Sodium, KHP - Acid, Lactic, Enzymatic Method |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1145, 862.1345, 862.1450, 862.1600, 862.1665 |
| Review panels | Clinical Chemistry |
| Registered establishments | Radiometer Solutions Sp. z o.o., Radiometer Sp. z o.o |
| Establishment registrations | 3007490412, 3013513377 |
| FEI numbers | 3007490412, 3013513377 |
| 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