510(k) K963213 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 23, 1996 |
| Received | Aug 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. HDL-Cholesterol gen.3.
For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma. Terminated |
LBS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.