QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121

About This 510(k) Submission

K043051 is an FDA 510(k) clearance for the QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on February 7, 2005, 95 days after receiving the submission on November 4, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3650.