ClearanceBrief
510(k) K933053 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF

ApplicantRoche Diagnostic Systems, Inc., Branchburg NJ, US
DecisionSubstantially Equivalent, Aug 30, 1993
ReceivedMay 26, 1993
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K933053

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.