510(k) K951319

ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION by Roche Diagnostic Systems, Inc. — Product Code DOE

K951319 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION". The FDA issued a decision of Substantially Equivalent on June 1, 1995. The device falls under product code DOE (Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.), a Class II device regulated under 21 CFR 862.3640. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.