510(k) K193567 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 >=16 ug/mL)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Feb 14, 2020 |
| Received | Dec 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193567
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2026 | Biomerieux Inc VITEK 2 Gram-negative Susceptibility Cards Containing
o Polymyxin B (pb02n)
o Ceftazidime/avibactam (cza02n)
o Meropenem/Vaborbactam (mev01n)
o Imipenem (ipm05n)
o Imipenem/Relebactam (ipr01n);
CARD Open, Classified |
LTW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.