510(k) K880237 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
CHOLESTEROL
| Applicant | Tech-Neal Scientific, Inc., Westmont IL, US |
| Decision | Substantially Equivalent, Apr 28, 1988 |
| Received | Jan 20, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880237
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2002 | Elan Diagnostics, Inc. Elan Diagnostics CHO ATAC Cholesterol Reagent Kit
Product Number: 516-250 Terminated |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.