510(k) K014069

LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC by Princeton BioMeditech Corp. — Product Code DIO

K014069 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC". The FDA issued a decision of Substantially Equivalent on June 10, 2002. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.