510(k) K821105 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
CHOLESTEZYME-V EIKEN
| Applicant | Syn-Kit, Inc., Walker MI, US |
| Decision | Substantially Equivalent, May 5, 1982 |
| Received | Apr 20, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821105
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.