ClearanceBrief
510(k) K980312 ยท DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

NOVA LITE ENDOMYSIAL

ApplicantInova Diagnostics, Inc., San Diego CA, US
DecisionSubstantially Equivalent, Apr 2, 1998
ReceivedJan 27, 1998
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K980312

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.