510(k) K030677 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, Apr 1, 2003 |
| Received | Mar 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030677
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2012 | Becton Dickinson & Co. Becton Dickinson Phoenix System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels.
Product Usage:
Automated Microb Terminated |
LON | None listed |
| May 24, 2012 | Becton Dickinson & Co. Becton Dickinson Phoenix Update Disks (PUD), catalog # 441107/ 448047, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels.
Product Usage:
The Phoenix Terminated |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.