510(k) K011079 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
K-ASSAY HS-CRP CONTROLS
| Applicant | Kamiya Biomedical Co., Seattle WA, US |
| Decision | Substantially Equivalent, May 16, 2001 |
| Received | Apr 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011079
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.