ClearanceBrief
510(k) K983423 ยท LLL Extractable Antinuclear Antibody, Antigen And Control

THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

ApplicantZeus Scientific, Inc., Branchburg NJ, US
DecisionSubstantially Equivalent, Nov 18, 1998
ReceivedSep 29, 1998
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K983423

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.