ClearanceBrief
510(k) K081104 ยท LKJ Antinuclear Antibody, Antigen, Control

AESKULISA ANA HEP-2, REF 30-7115US

ApplicantAesku Diagnostics, Wendelsheim, Rheinland, DE
DecisionSubstantially Equivalent, May 2, 2008
ReceivedApr 18, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K081104

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.