510(k) K200308 · JWY Manual Antimicrobial Susceptibility Test Systems
MTS Lefamulin 0.016- 256 µg/mL
| Applicant | Liofilchem S. R. 1., Roseto Degli Abruzzi, IT |
| Decision | Substantially Equivalent, Apr 6, 2020 |
| Received | Feb 6, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200308
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.