| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2026-01-22 | K251511 | PhenoMATRIX | Copan Wasp Srl | Microbiology |
| 2025-01-10 | K241676 | TriVerity | Inflammatix, Inc. | Microbiology |
| 2020-09-15 | K192665 | Accelerate Pheno System, Accelerate PhenoTest BC Kit | Accelerate Diagnostics, Inc. | Microbiology |
| 2019-05-15 | K183648 | APAS Independence with Urine Analysis Module | Clever Culture Systems AG | Microbiology |
| 2019-04-22 | K182513 | FluChip-8G Influenza A+B Assay | InDevR, Inc. | Microbiology |
| 2013-11-21 | K130831 | MALDI BIOTYPER CA (MBT-CA) SYSTEM | BRUKER DALTONICS, INC | Microbiology |
| 2013-08-21 | DEN130013 | VITEK MS | BIOMERIEUX, INC. | Microbiology |