510(k) K893916 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Aug 28, 1989 |
| Received | May 30, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893916
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.