510(k) K251580 · JWY Manual Antimicrobial Susceptibility Test Systems
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
| Applicant | Liofilchem s.r.l., Roseto Degli Abruzzi, IT |
| Decision | Substantially Equivalent, Aug 20, 2025 |
| Received | May 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251580
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.