510(k) K974733 ยท LBR Ldl & Vldl Precipitation, Hdl
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 26, 1998 |
| Received | Dec 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974733
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. LDL-Cholesterol plus gen.2.
The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma. Terminated |
LBR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.