510(k) K112523 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jan 6, 2012 |
| Received | Aug 31, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112523
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.