510(k) K002558 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
| Applicant | Kamiya Biomedical Co., Seattle WA, US |
| Decision | Substantially Equivalent, Oct 25, 2000 |
| Received | Aug 14, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002558
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.