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.

About This 510(k) Submission

K152551 is an FDA 510(k) clearance for the 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., a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on November 9, 2015, 62 days after receiving the submission on September 8, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.