510(k) K112910 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
AP 72OS SEMI-AUTOMATED INSTRUMENT
| Applicant | Hitachi Chemical Diagnostics, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Dec 20, 2012 |
| Received | Oct 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112910
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.