510(k) K100060 ยท KHS Enzymatic, Carbon-Dioxide
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
| Applicant | Vital Diagnostics (Manufacturing) Ptyltd, Noble Park, AU |
| Decision | Substantially Equivalent, Dec 15, 2010 |
| Received | Jan 11, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100060
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.