510(k) K183115 · JWY Manual Antimicrobial Susceptibility Test Systems
MTS Levofloxacin 0.002 - 32 µg/mL
| Applicant | Liofilchem s.r.l., Roseto Degli Abruzzi, IT |
| Decision | Substantially Equivalent, Dec 20, 2018 |
| Received | Nov 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183115
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.