K133642 - RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK
(FDA 510(k) Clearance)

K133642 is an FDA 510(k) clearance for the RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Biophor Diagnostics, Inc. (Redwood City, US). The FDA issued a Cleared decision on January 24, 2014, 58 days after receiving the submission on November 27, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.