Brønshøj, DK · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | Class II | Clinical Chemistry | 2 | 2026-04-10 |
| CGA | Glucose Oxidase, Glucose | Class II | Clinical Chemistry | 1 | 2026-05-01 |
| JGS | Electrode, Ion Specific, Sodium | Class II | Clinical Chemistry | 1 | 2026-05-01 |
| CEM | Electrode, Ion Specific, Potassium | Class II | Clinical Chemistry | 1 | 2025-01-14 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-01 | K252488 | ABL90 FLEX PLUS System | CGA | Class II | Clinical Chemistry |
| 2026-05-01 | K252475 | ABL90 FLEX PLUS System | JGS | Class II | Clinical Chemistry |
| 2026-04-10 | K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | CHL | Class II | Clinical Chemistry |
| 2025-01-14 | K241037 | ABL90 FLEX PLUS System | CEM | Class II | Clinical Chemistry |
| 2024-12-13 | K240998 | ABL90 FLEX PLUS System | CHL | Class II | Clinical Chemistry |