510(k) K862507 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)
| Applicant | Sclavo, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Jul 16, 1986 |
| Received | Jul 1, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862507
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.