510(k) K182793 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
AP3600 Automated Instrument
| Applicant | Hitachi Chemical Diagnostics, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Mar 19, 2019 |
| Received | Oct 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182793
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.