ClearanceBrief
510(k) K121946 ยท CDD Radioassay, Vitamin B12

AXIS-SHIELD ACVTIVE-B12

ApplicantAxis-Shield Diagnostics, Ltd., Dundee, Scotland, GB
DecisionSubstantially Equivalent, Mar 22, 2013
ReceivedJul 3, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K121946

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.