510(k) K163406 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 11, 2017 |
| Received | Dec 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163406
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.