510(k) K913565 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
ABBOTT QUICKSTART CHOLESTEROL TEST
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Dec 18, 1991 |
| Received | Aug 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913565
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.