510(k) K840368 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
DURAZYME CHOLESTEROL
| Applicant | American Monitor Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 30, 1984 |
| Received | Jan 27, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840368
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.