ClearanceBrief
510(k) K113863 ยท MST Antibodies, Gliadin

QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS

ApplicantInova Diagnostics, Inc., San Diego CA, US
DecisionSubstantially Equivalent, Sep 20, 2012
ReceivedDec 30, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K113863

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.