510(k) K033458 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, May 28, 2004 |
| Received | Oct 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033458
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2011 | Becton Dickinson & Co. BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***
The BD Phoenix Terminated |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.