ClearanceBrief
510(k) K242531 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis famili

ApplicantHycor Biomedical, Garden Grove CA, US
DecisionSubstantially Equivalent, Apr 23, 2025
ReceivedAug 26, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K242531

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.