ClearanceBrief
510(k) K822682 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K

ApplicantAmico Lab, Inc., Walker MI, US
DecisionSubstantially Equivalent, Dec 3, 1982
ReceivedSep 3, 1982
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K822682

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.