510(k) K023853 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
K-ASSAY LP(A) CONTROLS
| Applicant | Kamiya Biomedical Co., Seattle WA, US |
| Decision | Substantially Equivalent, Dec 13, 2002 |
| Received | Nov 19, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023853
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Kamiya Biomedical Company K-Assay Lp(a) Control Terminated |
DFC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.