510(k) K161217 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jan 12, 2017 |
| Received | Apr 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161217
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2024 | Biomerieux Inc VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility):
a) AST-N334, REF 418984;
b) AST-GN95, REF 421982;
c) AST-GN99, REF 423102;
d) AST-N390, REF 423340;
e) Open, Classified |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.