510(k) K253573 ยท SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
ASTar BC G- Kit
| Applicant | Q-Linea AB, Uppsala, SE |
| Decision | Substantially Equivalent, Apr 15, 2026 |
| Received | Nov 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253573
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.