510(k) K992803 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Sep 13, 1999 |
| Received | Aug 19, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992803
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.