510(k) K191809 · JWY Manual Antimicrobial Susceptibility Test Systems
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
| Applicant | Liofilchem s.r.l., Roseto Degli Abruzzi, IT |
| Decision | Substantially Equivalent, Aug 23, 2019 |
| Received | Jul 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191809
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.