510(k) K211759 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Selux AST System; Model AST Gen 1.0
| Applicant | Selux Diagnostics, Inc., Charlestown MA, US |
| Decision | Substantially Equivalent, Jan 18, 2023 |
| Received | Jun 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211759
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.