510(k) K253316 ยท SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
PhAST instrument and PhAST Blood Culture Gram-negative Panel
| Applicant | Phast Corp., Boston MA, US |
| Decision | Substantially Equivalent, Jun 26, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253316
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.