510(k) K220162 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
| Applicant | Hycor Biomedical, Garden Grove CA, US |
| Decision | Substantially Equivalent, Feb 18, 2022 |
| Received | Jan 20, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220162
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.