510(k) K082488 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
DIAZYME LP(A) ASSAY
| Applicant | General Atomics, Poway CA, US |
| Decision | Substantially Equivalent, Jan 13, 2009 |
| Received | Aug 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082488
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.