510(k) K251879 · JTN Susceptibility Test Discs, Antimicrobial
Sulopenem SPM 2 µg
| Applicant | Liofilchem, Waltham MA, US |
| Decision | Substantially Equivalent, Aug 12, 2025 |
| Received | Jun 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251879
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.