510(k) K152551

First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test. by W.H.P.M., Inc. — Product Code DJG

K152551 is an FDA 510(k) premarket notification submitted by W.H.P.M., Inc. for the device "First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test.". The FDA issued a decision of Substantially Equivalent on November 9, 2015. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. W.H.P.M., Inc. has at least 10 other 510(k) clearances on record.