510(k) K191510 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae
| Applicant | Hycor Biomedical, Garden Grove CA, US |
| Decision | Substantially Equivalent, Jul 31, 2019 |
| Received | Jun 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191510
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.