| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Class II | Microbiology | 2 | 2023-12-27 |
| QQV | Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry | Class II | Microbiology | 2 | 2023-03-20 |
| PPU | Microbial Colony Image Assessment System | Class II | Microbiology | 1 | 2026-01-22 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-22 | K251511 | PhenoMATRIX | PPU | Class II | Microbiology |
| 2023-12-27 | K232756 | Colibrí | LON | Class II | Microbiology |
| 2023-03-20 | K223245 | Colibrí | QQV | Class II | Microbiology |
| 2022-10-05 | K220546 | Colibrí System | LON | Class II | Microbiology |
| 2021-12-27 | K193138 | Colibri System | QQV | Class II | Microbiology |