510(k) K897162 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
COULTER CHOLESTEROL REAGENT
| Applicant | Coulter Electronics, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Mar 29, 1990 |
| Received | Dec 28, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897162
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.