510(k) K041090 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
HDL-EX SEIKEN ASSAY KIT
| Applicant | Denka Seiken Co., Ltd., Niigata, JP |
| Decision | Substantially Equivalent, Oct 29, 2004 |
| Received | Apr 26, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041090
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.