510(k) K191953 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
| Applicant | Biomerieux S.A., Marcy-L'Etoile, FR |
| Decision | Substantially Equivalent, Aug 22, 2019 |
| Received | Jul 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191953
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927 Open, Classified |
JWY | None listed |
| Jun 24, 2021 | Biomerieux Inc ETEST IMIPENEM RELEBACTAM. in vitro diagnostic Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.