510(k) K860525

ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD by Roche Diagnostic Systems, Inc. — Product Code DLB

K860525 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD". The FDA issued a decision of Substantially Equivalent on April 11, 1986. The device falls under product code DLB (Radioimmunoassay, Lsd (125-I)), a Class II device regulated under 21 CFR 862.3580. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.