510(k) K981181 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)
| Applicant | Actimed Laboratories, Inc., Burlington NJ, US |
| Decision | Substantially Equivalent, Aug 3, 1998 |
| Received | Apr 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981181
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.