510(k) K260331 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)
| Applicant | Siemens Healthcare Diagnostics Products, Ltd., Llanberis, GB |
| Decision | Substantially Equivalent, Sep 4, 2026 |
| Received | Feb 2, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260331
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.