510(k) K961436

ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) by Roche Diagnostic Systems, Inc. — Product Code DLB

K961436 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)". The FDA issued a decision of Substantially Equivalent on June 21, 1996. 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.