510(k) K051677 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
OPTIGEN ALLERGEN SPECIFIC IGE ASSAY
| Applicant | Hitachi Chemical Diagnostics, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Jan 23, 2006 |
| Received | Jun 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051677
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2013 | Hitachi Chemical Diagnostics Inc OPTIGEN Food 30; Catalog number: 85035. For allergen testing.
Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA.
Distributed by Theridiag, Cedex, France Terminated |
DHB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.