510(k) K082538 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, Nov 20, 2008 |
| Received | Sep 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082538
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2017 | Becton Dickinson & Co. BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD.
PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The indu Terminated |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.