Accelerate Pheno System, Accelerate PhenoTest BC Kit is an AI-enabled medical device from Accelerate Diagnostics, Inc., listed by FDA (510(k), K192665) with a decision date of 2020-09-15. Review panel: Microbiology.
| FDA submission number | K192665 |
|---|---|
| Pathway | 510(k) |
| Company | Accelerate Diagnostics, Inc. |
| Review panel (specialty) | Microbiology |
| FDA decision date | 2020-09-15 |
| Decision | Substantially Equivalent |
| Product code | PRH |
| Classification | Positive Blood Culture Identification And Ast Kit |
| Device class | 2 |
| Regulation number | 866.1650 |
| Review time (calendar days) | 356 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.