510(k) K935136 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Dec 16, 1993 |
| Received | Oct 28, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935136
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.