510(k) K885023 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
CHOLESTEROL TEST ITEM NUMBER: SR1011
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Feb 17, 1989 |
| Received | Dec 5, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885023
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.