510(k) K212181 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Aug 3, 2022 |
| Received | Jul 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212181
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.