510(k) K132801 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, May 28, 2014 |
| Received | Sep 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132801
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.