510(k) K021954 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, Aug 1, 2002 |
| Received | Jun 14, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021954
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2010 | Becton Dickinson & Co. BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663*** Terminated |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.