510(k) K251875 ยท SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
| Applicant | Affinity Biosensors, LLC, Santa Barbara CA, US |
| Decision | Substantially Equivalent, Oct 27, 2025 |
| Received | Jun 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251875
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.