510(k) K030590 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
| Applicant | Hitachi Chemical Diagnostics, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Mar 21, 2003 |
| Received | Feb 25, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030590
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.