ClearanceBrief
510(k) K162395 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup

ApplicantMp Biomedicals, LLC, Burlingame CA, US
DecisionSubstantially Equivalent, Jun 2, 2017
ReceivedAug 26, 2016
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K162395

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.