ClearanceBrief
510(k) K984462 ยท LLL Extractable Antinuclear Antibody, Antigen And Control

LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206

ApplicantBio-Rad, Irvine CA, US
DecisionSubstantially Equivalent, Dec 22, 1998
ReceivedDec 16, 1998
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K984462

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.