510(k) K973069

SYNCHRON SYSTEMS METHADONE REAGENT by Beckman Instruments, Inc. — Product Code DJR

K973069 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "SYNCHRON SYSTEMS METHADONE REAGENT". The FDA issued a decision of Substantially Equivalent on Sep 22, 1997. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.