ClearanceBrief
510(k) K040101 ยท NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

MODIFICATION TO DIADEXUS PLAC TEST

ApplicantDiadexus, Inc., South San Francisco CA, US
DecisionSubstantially Equivalent, Feb 5, 2004
ReceivedJan 20, 2004
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K040101

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.