510(k) K200825 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense
| Applicant | Hycor Biomedical, Garden Grove CA, US |
| Decision | Substantially Equivalent, Jun 26, 2020 |
| Received | Mar 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200825
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.