510(k) K142353

First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test by W.H.P.M., Inc. — Product Code DIO

K142353 is an FDA 510(k) premarket notification submitted by W.H.P.M., Inc. for the device "First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test". The FDA issued a decision of Substantially Equivalent on October 7, 2014. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. W.H.P.M., Inc. has at least 10 other 510(k) clearances on record.