510(k) K182922 · JWY Manual Antimicrobial Susceptibility Test Systems
MTS Omadacycline 0.002-32 µg/mL
| Applicant | Liofilchem s.r.l., Roseto Degli Abruzzi, IT |
| Decision | Substantially Equivalent, Dec 14, 2018 |
| Received | Oct 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182922
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.