510(k) K050745 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, Apr 29, 2005 |
| Received | Mar 22, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050745
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2018 | Becton Dickinson & Co. Phoenix AST-s Indicator, Catalog Number 246009 Terminated |
LON | None listed |
| Dec 20, 2018 | Becton Dickinson & Co. Phoenix AST Indicator, Catalog Number 246004 Terminated |
LON | None listed |
| Dec 20, 2018 | Becton Dickinson & Co. Phoenix AP AST Indicator Bag, Catalog Number 246006 Terminated |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.