510(k) K110583 ยท LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
SENSITITRE OPTIREAD
| Applicant | Trek Diagnostic Systems, Ltd., Cleveland OH, US |
| Decision | Substantially Equivalent, Sep 22, 2011 |
| Received | Mar 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110583
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.