510(k) K081378

DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS by Thermo Fisher Scientific — Product Code DJR

K081378 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS". The FDA issued a decision of Substantially Equivalent on January 14, 2009. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. Thermo Fisher Scientific has at least 10 other 510(k) clearances on record.