510(k) K854009

ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP by Roche Diagnostic Systems, Inc. — Product Code DJP

K854009 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP". The FDA issued a decision of Substantially Equivalent on October 15, 1985. The device falls under product code DJP (Radioimmunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.