510(k) K913722

ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE by Roche Diagnostic Systems, Inc. — Product Code KLN

K913722 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE". The FDA issued a decision of Substantially Equivalent on September 10, 1991. The device falls under product code KLN (Radioimmunoassay, Cocaine Metabolite), a Class II device regulated under 21 CFR 862.3250. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.