510(k) K935055

ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) by Roche Diagnostic Systems, Inc. — Product Code DOE

K935055 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)". The FDA issued a decision of Substantially Equivalent on August 9, 1994. 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.