510(k) K070809 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, Sep 24, 2007 |
| Received | Mar 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070809
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2022 | Becton Dickinson & Co. BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selecte Open, Classified |
LON | None listed |
| Dec 19, 2012 | Becton Dickinson & Co. BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA.
The BD Phoenix" Automated Microbiology system is intended for the rap Terminated |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.