FluChip-8G Influenza A+B Assay is an AI-enabled medical device from InDevR, Inc., listed by FDA (510(k), K182513) with a decision date of 2019-04-22. Review panel: Microbiology.
| FDA submission number | K182513 |
|---|---|
| Pathway | 510(k) |
| Company | InDevR, Inc. |
| Review panel (specialty) | Microbiology |
| FDA decision date | 2019-04-22 |
| Decision | Substantially Equivalent |
| Product code | OZE |
| Classification | Influenza A And Influenza B Multiplex Nucleic Acid Assay |
| Device class | 2 |
| Regulation number | 866.3980 |
| Review time (calendar days) | 222 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Microbiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.