ClearanceBrief
510(k) K101853 ยท NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115

ApplicantDiadexus, Inc., South San Francisco CA, US
DecisionSubstantially Equivalent, Jan 3, 2011
ReceivedJul 1, 2010
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K101853

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.