510(k) K980667 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Apr 21, 1998 |
| Received | Feb 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980667
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.