510(k) K043264 ยท MRR System, Test, Low Density, Lipoprotein
LDL-EX SEIKEN ASSAY KIT
| Applicant | Denka Seiken Co., Ltd., Gosen-Shi, Niigata, JP |
| Decision | Substantially Equivalent, Jan 26, 2005 |
| Received | Nov 24, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043264
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.