Charlestown, MA, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QZX | Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing | Class II | Microbiology | 2 | 2025-03-28 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Class II | Microbiology | 2 | 2023-04-19 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-03-28 | K244044 | PBC Separator with Selux AST System | QZX | Class II | Microbiology |
| 2024-02-15 | K223493 | PBC Separator with Selux AST System | QZX | Class II | Microbiology |
| 2023-04-19 | K211748 | Selux AST System; Model AST Gen 1.0 | LON | Class II | Microbiology |
| 2023-01-18 | K211759 | Selux AST System; Model AST Gen 1.0 | LON | Class II | Microbiology |