510(k) K925603 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
OLYMPUS CHOLESTEROL REAGENT
| Applicant | Olympus Corp., Lake Success NY, US |
| Decision | Substantially Equivalent, Feb 8, 1993 |
| Received | Nov 5, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925603
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2015 | Beckman Coulter Inc. Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16 Terminated |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.