510(k) K110331 ยท LIE Reagent/Device, Inoculum Calibration
SENSITITRE AIM (TM)
| Applicant | Trek Diagnostic Systems, Ltd., Cleveland OH, US |
| Decision | Substantially Equivalent, Apr 27, 2011 |
| Received | Feb 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110331
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.