ClearanceBrief
510(k) K053035 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000

ApplicantAcro Biotech, LLC, Rancho Cucamonga CA, US
DecisionSubstantially Equivalent, May 5, 2006
ReceivedOct 27, 2005
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K053035

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.