510(k) K924508 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
CHOLESTEROL TEST ITEM# 42374/93, 42322/R1
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jan 28, 1993 |
| Received | Sep 4, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924508
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.