510(k) K211815 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, Santa Barbara CA, US |
| Decision | Substantially Equivalent, Apr 2, 2024 |
| Received | Jun 11, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211815
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.