ClearanceBrief
510(k) K033713 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A

ApplicantDade Behring, Inc., Newark, DE, US
DecisionSubstantially Equivalent, Feb 9, 2004
ReceivedNov 26, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K033713

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.