510(k) K830480

ABUSCREEN RADIOIMMUNOASSAY-COCAINE META by Hoffmann-La Roche, Inc. — Product Code KLN

K830480 is an FDA 510(k) premarket notification submitted by Hoffmann-La Roche, Inc. for the device "ABUSCREEN RADIOIMMUNOASSAY-COCAINE META". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code KLN (Radioimmunoassay, Cocaine Metabolite), a Class II device regulated under 21 CFR 862.3250. Hoffmann-La Roche, Inc. has at least 10 other 510(k) clearances on record.