ClearanceBrief
510(k) K842563 ยท LKJ Antinuclear Antibody, Antigen, Control

SERATEST DNA DETERMINATION

ApplicantSeragen Diagnostics, Inc., Indianapolis IN, US
DecisionSubstantially Equivalent, Oct 25, 1984
ReceivedJul 2, 1984
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K842563

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.