Montpellier Cedex 4, FR · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GKZ | Counter, Differential Cell | Class II | Hematology | 2 | 2026-09-14 |
| JFY | Enzymatic Method, Creatinine | Class II | Clinical Chemistry | 1 | 2021-05-10 |
| CZP | Iga, Antigen, Antiserum, Control | Class II | Immunology | 1 | 2020-06-26 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | Class II | Immunology | 1 | 2020-06-25 |
| DBF | Ferritin, Antigen, Antiserum, Control | Class II | Immunology | 1 | 2020-03-06 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-14 | K260781 | Yumizen H550 | GKZ | Class II | Hematology |
| 2024-05-21 | K232946 | Yumizen H2500 | GKZ | Class II | Hematology |
| 2021-05-10 | K193649 | Yumizen C1200 Creatinine PAP | JFY | Class II | Clinical Chemistry |
| 2020-06-26 | K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | CZP | Class II | Immunology |
| 2020-06-25 | K192028 | Yumizen C1200 CRP | DCK | Class II | Immunology |
| 2020-03-06 | K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor | DBF | Class II | Immunology |