510(k) K870828 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT
| Applicant | Intersect Systems, Inc., Longview WA, US |
| Decision | Substantially Equivalent, Mar 13, 1987 |
| Received | Mar 3, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870828
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.