510(k) K111960 ยท KHS Enzymatic, Carbon-Dioxide
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS
| Applicant | Elitechgroup, Bothell WA, US |
| Decision | Substantially Equivalent, Nov 18, 2011 |
| Received | Jul 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111960
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.