510(k) K951892

ONE STEP URINE DRUG OF ABUSE COCAINE TEST by Tcpi, Inc. — Product Code DIO

K951892 is an FDA 510(k) premarket notification submitted by Tcpi, Inc. for the device "ONE STEP URINE DRUG OF ABUSE COCAINE TEST". The FDA issued a decision of Substantially Equivalent on August 17, 1995. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Tcpi, Inc. has at least 10 other 510(k) clearances on record.