510(k) K091289 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
| Applicant | Siemens Healthcare Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, Aug 6, 2009 |
| Received | May 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091289
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.