510(k) K881816

ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES by Roche Diagnostic Systems, Inc. — Product Code DKN

K881816 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES". The FDA issued a decision of Substantially Equivalent on July 28, 1988. The device falls under product code DKN (Radioimmunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.