Malvern, PA, US · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OVK | Cytokeratin Fragments 21-1 Eia Kit | Class II | Immunology | 1 | 2025-12-16 |
| SET | Immunoassay Blood Test For Amyloid Pathology Assessment | Class II | Immunology | 1 | 2025-05-16 |
| QSE | AlzheimerS Disease Pathology Assessment Test | Class II | Immunology | 1 | 2022-05-04 |
| MOI | System, Test, Immunological, Antigen, Tumor | Class II | Immunology | 1 | 2020-09-04 |
| NBC | — | — | — | 1 | 2020-08-24 |
| NIG | — | — | — | 1 | 2020-05-14 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-12-16 | K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | OVK | Class II | Immunology |
| 2025-05-16 | K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | SET | Class II | Immunology |
| 2022-05-04 | DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | QSE | Class II | Immunology |
| 2020-09-04 | K192524 | Lumipulse G CA15-3 | MOI | Class II | Immunology |
| 2020-08-24 | K192380 | ST AIA-PACK BNP | NBC | — | — |
| 2020-05-14 | K200997 | Lumipulse G CA19-9-N | NIG | — | — |