510(k) K193613 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
Allergen-Specific IgE Assay 12 Allergen Bundle
| Applicant | Hitachi Chemical Diagnostics, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Oct 18, 2021 |
| Received | Dec 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193613
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.