ClearanceBrief
510(k) K000879 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

ApplicantZeus Scientific, Inc., Branchburg NJ, US
DecisionSubstantially Equivalent, May 22, 2000
ReceivedMar 20, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K000879

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.