510(k) K842160 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
CHOLESTEROL ASSSAY KIT
| Applicant | Diagnostic Chemicals, Ltd. (Usa), Canada, US |
| Decision | Substantially Equivalent, Aug 17, 1984 |
| Received | May 30, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842160
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2010 | Diagnostic Chemicals, Ltd. Genzyme Diagnostics Total Serum Cholesterol Kit, IVD
Catalog Number: 225-26
Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum. Terminated |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.