510(k) K813039 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
ULTRACHEM E-CHOL, ITEM #65025
| Applicant | Harleco, Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 10, 1981 |
| Received | Oct 28, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813039
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.