ClearanceBrief
510(k) K180202 ยท DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts

ApplicantImmuno Concepts, N.A. , Ltd., Sacramento CA, US
DecisionSubstantially Equivalent, Oct 19, 2018
ReceivedJan 24, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K180202

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.