510(k) K050400 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, Mar 22, 2005 |
| Received | Feb 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050400
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2007 | GE OEC Medical Systems, Inc GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems. GE Health Medical Systems, Inc, Salt Lake City, UT 84116-2862 Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.