ClearanceBrief
510(k) K020566 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

FUJIREBIO DIAGNOSTICS CA 19-9 RIA

ApplicantFujirebio Diagnostics,Inc., Malvern PA, US
DecisionSubstantially Equivalent, May 9, 2002
ReceivedFeb 20, 2002
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K020566

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.