510(k) K192345 · JWY Manual Antimicrobial Susceptibility Test Systems
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
| Applicant | Liofilchem s.r.l., Roseto Degli Abruzzi, IT |
| Decision | Substantially Equivalent, Oct 31, 2019 |
| Received | Aug 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192345
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.