510(k) K011958 ยท DCN System, Test, C-Reactive Protein
CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
| Applicant | Denka Seiken'S, Tokyo, JP |
| Decision | Substantially Equivalent, Dec 4, 2001 |
| Received | Jun 22, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011958
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.