ClearanceBrief
510(k) K010564 ยท DKZ Enzyme Immunoassay, Amphetamine

VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO

ApplicantMedtox Diagnostics, Inc., Burlington NC, US
DecisionSubstantially Equivalent, Apr 5, 2001
ReceivedFeb 26, 2001
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K010564

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.