510(k) K000378 ยท MDB System, Blood Culturing
BACT/ALERT MB CULTURE BOTTLE
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Mar 2, 2000 |
| Received | Feb 7, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000378
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.