510(k) K952127 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 20, 1995 |
| Received | May 8, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952127
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. Cholesterol CHOD-PAP.
In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma. Terminated |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.