510(k) K992401 ยท MDB System, Blood Culturing
BACT/ALERT PF
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Sep 3, 1999 |
| Received | Jul 19, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992401
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.