510(k) K103456 ยท LIE Reagent/Device, Inoculum Calibration
THE SENSITITRE AIM
| Applicant | Trek Diagnostic Systems, Cleveland OH, US |
| Decision | Substantially Equivalent, Jun 22, 2011 |
| Received | Nov 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103456
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.